{
"NDC": [
{
"NDCCode": "50090-0643-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-0643-0) ",
"NDC11Code": "50090-0643-00",
"ProductNDC": "50090-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077309",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablets are a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "50090-0643-1",
"PackageDescription": "21 TABLET in 1 BOTTLE (50090-0643-1) ",
"NDC11Code": "50090-0643-01",
"ProductNDC": "50090-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077309",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191023",
"SamplePackage": "N",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablets are a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "50701-0643-0",
"PackageDescription": "1 BAG in 1 DRUM (50701-0643-0) > 10 kg in 1 BAG",
"NDC11Code": "50701-0643-00",
"ProductNDC": "50701-0643",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20071003",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "UCB Manufacturing Ireland Limited",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70518-0643-0",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70518-0643-0) ",
"NDC11Code": "70518-0643-00",
"ProductNDC": "70518-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170728",
"SamplePackage": "N"
},
{
"NDCCode": "0173-0643-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (0173-0643-60) ",
"NDC11Code": "00173-0643-60",
"ProductNDC": "0173-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamictal",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020241",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19950117",
"SamplePackage": "N",
"IndicationAndUsage": "LAMICTAL is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. LAMICTAL tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only). LAMICTAL tablets for oral suspension are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension. LAMICTAL ODT orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose. LAMICTAL ODT orally disintegrating tablets are formulated using technologies (Microcaps and AdvaTab) designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study in 108 healthy volunteers."
},
{
"NDCCode": "16590-643-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (16590-643-28)",
"NDC11Code": "16590-0643-28",
"ProductNDC": "16590-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078881",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed."
},
{
"NDCCode": "16590-643-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-643-30)",
"NDC11Code": "16590-0643-30",
"ProductNDC": "16590-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078881",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed."
},
{
"NDCCode": "16590-643-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-643-60)",
"NDC11Code": "16590-0643-60",
"ProductNDC": "16590-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078881",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed."
},
{
"NDCCode": "16590-643-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (16590-643-90)",
"NDC11Code": "16590-0643-90",
"ProductNDC": "16590-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078881",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed."
},
{
"NDCCode": "16714-643-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (16714-643-01) > 3 mL in 1 BOTTLE",
"NDC11Code": "16714-0643-01",
"ProductNDC": "16714-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206242",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171004",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacterium species*Micrococcus luteus*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri*Streptococcus pneumoniaeStreptococcus viridans groupAcinetobacter lwoffii*Haemophilus influenzaHaemophilus parainfluenzae*Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Moxifloxacin ophthalmic solution USP, 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride USP is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro- 6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C21H24FN3O4HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride USP is a slightly yellow to yellow powder or crystals, slightly hygroscopic. Each mL of moxifloxacin ophthalmic solution, USP contains 5.45 mg moxifloxacin hydrochloride USP, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution, USP contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "42549-643-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42549-643-30)",
"NDC11Code": "42549-0643-30",
"ProductNDC": "42549-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077712",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42549-643-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42549-643-60)",
"NDC11Code": "42549-0643-60",
"ProductNDC": "42549-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077712",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "44567-643-10",
"PackageDescription": "10 BAG in 1 CARTON (44567-643-10) / 250 mL in 1 BAG (44567-643-01) ",
"NDC11Code": "44567-0643-10",
"ProductNDC": "44567-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine Bitartrate In Sodium Chloride",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215700",
"LabelerName": "WG Critical Care, LLC",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": ".128",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine Bitartrate in Sodium Chloride Injection contains the active pharmaceutical ingredient norepinephrine, a catecholamine, in the form of bitartrate salt (monohydrate). Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. The chemical name for norepinephrine bitartrate (monohydrate) is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. Norepinephrine bitartrate (monohydrate) is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection is supplied as a sterile aqueous ready-to-use solution in 250 mL transparent intravenous bags. Each mL contains 32 mcg, 64 mcg, 128 mcg or 256 mcg of norepinephrine bitartrate monohydrate, equivalent to 16 mcg, 32 mcg, 64 mcg or 128 mcg of norepinephrine base, respectively. Each mL also contains 9 mg of Sodium Chloride USP as a tonicity agent, and may contain Hydrochloric Acid NF and Sodium Hydroxide NF as pH adjusters, for a pH range of 3.4 to 4.0, in Water for Injection."
},
{
"NDCCode": "45865-643-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-30) ",
"NDC11Code": "45865-0643-30",
"ProductNDC": "45865-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110610",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020699",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150911",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "45865-643-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-60) ",
"NDC11Code": "45865-0643-60",
"ProductNDC": "45865-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110610",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020699",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150911",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "49281-643-15",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-643-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-643-78) ",
"NDC11Code": "49281-0643-15",
"ProductNDC": "49281-643",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Trivalent Northern Hemisphere",
"NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20250701",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250701",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Fluzone® is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.",
"Description": "Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2025-2026 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Croatia/10136RV/2023 X-425A (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
},
{
"NDCCode": "49288-0643-1",
"PackageDescription": "2 mL in 1 VIAL, MULTI-DOSE (49288-0643-1)",
"NDC11Code": "49288-0643-01",
"ProductNDC": "49288-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jack Pine Pollen",
"NonProprietaryName": "Jack Pine Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINUS BANKSIANA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0643-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0643-2)",
"NDC11Code": "49288-0643-02",
"ProductNDC": "49288-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jack Pine Pollen",
"NonProprietaryName": "Jack Pine Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINUS BANKSIANA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0643-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0643-3)",
"NDC11Code": "49288-0643-03",
"ProductNDC": "49288-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jack Pine Pollen",
"NonProprietaryName": "Jack Pine Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINUS BANKSIANA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0643-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0643-4)",
"NDC11Code": "49288-0643-04",
"ProductNDC": "49288-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jack Pine Pollen",
"NonProprietaryName": "Jack Pine Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINUS BANKSIANA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "49288-0643-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0643-5)",
"NDC11Code": "49288-0643-05",
"ProductNDC": "49288-0643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jack Pine Pollen",
"NonProprietaryName": "Jack Pine Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PINUS BANKSIANA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "51862-643-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10) ",
"NDC11Code": "51862-0643-10",
"ProductNDC": "51862-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075797",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210827",
"SamplePackage": "N",
"IndicationAndUsage": "Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.",
"Description": "Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows:. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL."
},
{
"NDCCode": "51862-643-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51862-643-30) ",
"NDC11Code": "51862-0643-30",
"ProductNDC": "51862-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075797",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210827",
"SamplePackage": "N",
"IndicationAndUsage": "Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.",
"Description": "Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows:. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL."
},
{
"NDCCode": "59088-643-54",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (59088-643-54) ",
"NDC11Code": "59088-0643-54",
"ProductNDC": "59088-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexatran",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "CAPSULE",
"RouteName": "CUTANEOUS; ORAL",
"StartMarketingDate": "20230215",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE; MANGANESE SULFATE; FERROUS FUMARATE; CUPRIC SULFATE",
"StrengthNumber": "6.9; 6; 30; 5; 1; 15; 10; 200; 10; 18.2; 1.3; 18; .8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230215",
"SamplePackage": "N",
"IndicationAndUsage": "Dexatran is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Active ingredients: Each capsule contains: Vitamin C (as sodium ascorbate).................................200 mg Thiamin (as thiamine mononitrate)............................... 10 mg Riboflavin....................................................................... 6 mg Niacin (as niacinamide)................................................ 30 mg Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin).............................. 15 mcg Pantothenic Acid (as d-calcium pantothenate)............. 10 mg Iron (as ferrous fumarate)............................................ 18 mg Magnesium (as magnesium sulfate)............................ 6.9 mg Zinc (as zinc sulfate).................................................. 18.2 mg Copper (as cupric sulfate)........................................... 0.8 mg Manganese (as manganese sulfate)............................ 1.3 mg. Other Ingredients: Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule."
},
{
"NDCCode": "60760-643-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (60760-643-30) ",
"NDC11Code": "60760-0643-30",
"ProductNDC": "60760-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077443",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190114",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets USP may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. Atenolol is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows. (See DOSAGE AND ADMNISTRATION, CONTRAINDICATIONSand WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine."
},
{
"NDCCode": "60760-643-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (60760-643-90) ",
"NDC11Code": "60760-0643-90",
"ProductNDC": "60760-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077443",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190607",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets USP may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. Atenolol is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows. (See DOSAGE AND ADMNISTRATION, CONTRAINDICATIONSand WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine."
},
{
"NDCCode": "61314-643-05",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (61314-643-05) ",
"NDC11Code": "61314-0643-05",
"ProductNDC": "61314-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19950109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062535",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2022-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950109",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.",
"Description": "Tobramycin ophthalmic solution, USP 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of tobramycin ophthalmic solution, USP 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. Tobramycin ophthalmic solution, USP 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. MW=467.52. Molecular Formula: C18H37N5O9. Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)} -0- {2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→6) }-2-deoxystreptamine."
},
{
"NDCCode": "61919-643-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (61919-643-10) ",
"NDC11Code": "61919-0643-10",
"ProductNDC": "61919-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203584",
"LabelerName": "Direct_Rx",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190812",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Acute Bacterial Exacerbation of Chronic Bronchitis. Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia. Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:. Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae. 1.4 Pharyngitis/Tonsillitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. 1.5 Uncomplicated Skin and Skin Structure Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Acute Otitis Media. Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] . 1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] . 1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease. Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. 1.9 Limitations of Use. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is. [chemical structure]. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "61919-643-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (61919-643-20) ",
"NDC11Code": "61919-0643-20",
"ProductNDC": "61919-643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203584",
"LabelerName": "Direct_Rx",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191106",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Acute Bacterial Exacerbation of Chronic Bronchitis. Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia. Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:. Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae. 1.4 Pharyngitis/Tonsillitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. 1.5 Uncomplicated Skin and Skin Structure Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Acute Otitis Media. Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] . 1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] . 1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease. Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. 1.9 Limitations of Use. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is. [chemical structure]. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol."
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"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (61919-643-28) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "1.1 Acute Bacterial Exacerbation of Chronic Bronchitis. Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia. Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:. Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae. 1.4 Pharyngitis/Tonsillitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. 1.5 Uncomplicated Skin and Skin Structure Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Acute Otitis Media. Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] . 1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] . 1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease. Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. 1.9 Limitations of Use. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is. [chemical structure]. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol."
}
]
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<PackageDescription>90 TABLET in 1 BOTTLE (50090-0643-0) </PackageDescription>
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<ProductNDC>50090-0643</ProductNDC>
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<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablets are a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
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<PackageDescription>21 TABLET in 1 BOTTLE (50090-0643-1) </PackageDescription>
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<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablets are a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
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<NDCCode>50701-0643-0</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (50701-0643-0) > 10 kg in 1 BAG</PackageDescription>
<NDC11Code>50701-0643-00</NDC11Code>
<ProductNDC>50701-0643</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20071003</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>UCB Manufacturing Ireland Limited</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<PackageDescription>30 TABLET in 1 BLISTER PACK (70518-0643-0) </PackageDescription>
<NDC11Code>70518-0643-00</NDC11Code>
<ProductNDC>70518-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0173-0643-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0173-0643-60) </PackageDescription>
<NDC11Code>00173-0643-60</NDC11Code>
<ProductNDC>0173-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamictal</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950117</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020241</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LAMICTAL is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. LAMICTAL tablets are supplied for oral administration as 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only). LAMICTAL tablets for oral suspension are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. The tablets for oral suspension meet Organic Impurities Procedure 2 as published in the current USP monograph for Lamotrigine Tablets for Oral Suspension. LAMICTAL ODT orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose. LAMICTAL ODT orally disintegrating tablets are formulated using technologies (Microcaps and AdvaTab) designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study in 108 healthy volunteers.</Description>
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<PackageDescription>28 TABLET in 1 BOTTLE (16590-643-28)</PackageDescription>
<NDC11Code>16590-0643-28</NDC11Code>
<ProductNDC>16590-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078881</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed.</Description>
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<PackageDescription>30 TABLET in 1 BOTTLE (16590-643-30)</PackageDescription>
<NDC11Code>16590-0643-30</NDC11Code>
<ProductNDC>16590-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078881</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed.</Description>
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<PackageDescription>60 TABLET in 1 BOTTLE (16590-643-60)</PackageDescription>
<NDC11Code>16590-0643-60</NDC11Code>
<ProductNDC>16590-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078881</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed.</Description>
</NDC>
<NDC>
<NDCCode>16590-643-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16590-643-90)</PackageDescription>
<NDC11Code>16590-0643-90</NDC11Code>
<ProductNDC>16590-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078881</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has an molecular formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 133 mg/mL in water. Each tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg. Inactive ingredients consist of: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. In addition, the following product specific coloring agents are employed.</Description>
</NDC>
<NDC>
<NDCCode>16714-643-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16714-643-01) > 3 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>16714-0643-01</NDC11Code>
<ProductNDC>16714-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206242</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacterium species*Micrococcus luteus*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri*Streptococcus pneumoniaeStreptococcus viridans groupAcinetobacter lwoffii*Haemophilus influenzaHaemophilus parainfluenzae*Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Moxifloxacin ophthalmic solution USP, 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride USP is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro- 6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C21H24FN3O4HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride USP is a slightly yellow to yellow powder or crystals, slightly hygroscopic. Each mL of moxifloxacin ophthalmic solution, USP contains 5.45 mg moxifloxacin hydrochloride USP, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution, USP contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>42549-643-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42549-643-30)</PackageDescription>
<NDC11Code>42549-0643-30</NDC11Code>
<ProductNDC>42549-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077712</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42549-643-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42549-643-60)</PackageDescription>
<NDC11Code>42549-0643-60</NDC11Code>
<ProductNDC>42549-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077712</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>44567-643-10</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (44567-643-10) / 250 mL in 1 BAG (44567-643-01) </PackageDescription>
<NDC11Code>44567-0643-10</NDC11Code>
<ProductNDC>44567-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine Bitartrate In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215700</ApplicationNumber>
<LabelerName>WG Critical Care, LLC</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>.128</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine Bitartrate in Sodium Chloride Injection contains the active pharmaceutical ingredient norepinephrine, a catecholamine, in the form of bitartrate salt (monohydrate). Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. The chemical name for norepinephrine bitartrate (monohydrate) is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula. Norepinephrine bitartrate (monohydrate) is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection is supplied as a sterile aqueous ready-to-use solution in 250 mL transparent intravenous bags. Each mL contains 32 mcg, 64 mcg, 128 mcg or 256 mcg of norepinephrine bitartrate monohydrate, equivalent to 16 mcg, 32 mcg, 64 mcg or 128 mcg of norepinephrine base, respectively. Each mL also contains 9 mg of Sodium Chloride USP as a tonicity agent, and may contain Hydrochloric Acid NF and Sodium Hydroxide NF as pH adjusters, for a pH range of 3.4 to 4.0, in Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>45865-643-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-30) </PackageDescription>
<NDC11Code>45865-0643-30</NDC11Code>
<ProductNDC>45865-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110610</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45865-643-60</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-60) </PackageDescription>
<NDC11Code>45865-0643-60</NDC11Code>
<ProductNDC>45865-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110610</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49281-643-15</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-643-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-643-78) </PackageDescription>
<NDC11Code>49281-0643-15</NDC11Code>
<ProductNDC>49281-643</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Trivalent Northern Hemisphere</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluzone® is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.</IndicationAndUsage>
<Description>Fluzone (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone. No presentation of Fluzone is made with natural rubber latex. Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2025-2026 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Croatia/10136RV/2023 X-425A (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
</NDC>
<NDC>
<NDCCode>49288-0643-1</NDCCode>
<PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0643-1)</PackageDescription>
<NDC11Code>49288-0643-01</NDC11Code>
<ProductNDC>49288-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jack Pine Pollen</ProprietaryName>
<NonProprietaryName>Jack Pine Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS BANKSIANA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0643-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0643-2)</PackageDescription>
<NDC11Code>49288-0643-02</NDC11Code>
<ProductNDC>49288-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jack Pine Pollen</ProprietaryName>
<NonProprietaryName>Jack Pine Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS BANKSIANA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0643-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0643-3)</PackageDescription>
<NDC11Code>49288-0643-03</NDC11Code>
<ProductNDC>49288-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jack Pine Pollen</ProprietaryName>
<NonProprietaryName>Jack Pine Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS BANKSIANA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0643-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0643-4)</PackageDescription>
<NDC11Code>49288-0643-04</NDC11Code>
<ProductNDC>49288-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jack Pine Pollen</ProprietaryName>
<NonProprietaryName>Jack Pine Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS BANKSIANA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0643-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0643-5)</PackageDescription>
<NDC11Code>49288-0643-05</NDC11Code>
<ProductNDC>49288-0643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jack Pine Pollen</ProprietaryName>
<NonProprietaryName>Jack Pine Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS BANKSIANA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>51862-643-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10) </PackageDescription>
<NDC11Code>51862-0643-10</NDC11Code>
<ProductNDC>51862-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamoxifen Citrate</ProprietaryName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075797</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows:. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.</Description>
</NDC>
<NDC>
<NDCCode>51862-643-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51862-643-30) </PackageDescription>
<NDC11Code>51862-0643-30</NDC11Code>
<ProductNDC>51862-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamoxifen Citrate</ProprietaryName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075797</ApplicationNumber>
<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows:. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.</Description>
</NDC>
<NDC>
<NDCCode>59088-643-54</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (59088-643-54) </PackageDescription>
<NDC11Code>59088-0643-54</NDC11Code>
<ProductNDC>59088-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexatran</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>CUTANEOUS; ORAL</RouteName>
<StartMarketingDate>20230215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE; MANGANESE SULFATE; FERROUS FUMARATE; CUPRIC SULFATE</SubstanceName>
<StrengthNumber>6.9; 6; 30; 5; 1; 15; 10; 200; 10; 18.2; 1.3; 18; .8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexatran is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Active ingredients: Each capsule contains: Vitamin C (as sodium ascorbate).................................200 mg Thiamin (as thiamine mononitrate)............................... 10 mg Riboflavin....................................................................... 6 mg Niacin (as niacinamide)................................................ 30 mg Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin).............................. 15 mcg Pantothenic Acid (as d-calcium pantothenate)............. 10 mg Iron (as ferrous fumarate)............................................ 18 mg Magnesium (as magnesium sulfate)............................ 6.9 mg Zinc (as zinc sulfate).................................................. 18.2 mg Copper (as cupric sulfate)........................................... 0.8 mg Manganese (as manganese sulfate)............................ 1.3 mg. Other Ingredients: Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule.</Description>
</NDC>
<NDC>
<NDCCode>60760-643-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (60760-643-30) </PackageDescription>
<NDC11Code>60760-0643-30</NDC11Code>
<ProductNDC>60760-643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077443</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets USP may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. Atenolol is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows. (See DOSAGE AND ADMNISTRATION, CONTRAINDICATIONSand WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine.</Description>
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<IndicationAndUsage>Hypertension. Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets USP may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. Atenolol is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows. (See DOSAGE AND ADMNISTRATION, CONTRAINDICATIONSand WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, hydroxypropyl methylcellulose, titanium dioxide and glycerine.</Description>
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<IndicationAndUsage>Tobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.</IndicationAndUsage>
<Description>Tobramycin ophthalmic solution, USP 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of tobramycin ophthalmic solution, USP 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. Tobramycin ophthalmic solution, USP 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. MW=467.52. Molecular Formula: C18H37N5O9. Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)} -0- {2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→6) }-2-deoxystreptamine.</Description>
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<IndicationAndUsage>1.1 Acute Bacterial Exacerbation of Chronic Bronchitis. Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia. Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:. Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae. 1.4 Pharyngitis/Tonsillitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. 1.5 Uncomplicated Skin and Skin Structure Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Acute Otitis Media. Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] . 1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] . 1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease. Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. 1.9 Limitations of Use. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is. [chemical structure]. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.</Description>
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<IndicationAndUsage>1.1 Acute Bacterial Exacerbation of Chronic Bronchitis. Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia. Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:. Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae. 1.4 Pharyngitis/Tonsillitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. 1.5 Uncomplicated Skin and Skin Structure Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Acute Otitis Media. Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] . 1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] . 1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease. Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. 1.9 Limitations of Use. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is. [chemical structure]. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.</Description>
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<IndicationAndUsage>1.1 Acute Bacterial Exacerbation of Chronic Bronchitis. Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia. Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:. Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae. 1.4 Pharyngitis/Tonsillitis. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. 1.5 Uncomplicated Skin and Skin Structure Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes. 1.6 Acute Otitis Media. Clarithromycin tablets, USP are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical Studies (14.2)] . 1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections. Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [see Clinical Studies (14.1)] . 1.8 Helicobacter pylori Infection and Duodenal Ulcer Disease. Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3)] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. 1.9 Limitations of Use. There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is. [chemical structure]. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.</Description>
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