{
"NDC": [
{
"NDCCode": "60687-417-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-417-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-417-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-417-44) ",
"NDC11Code": "60687-0417-71",
"ProductNDC": "60687-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211023",
"LabelerName": "American Health Packaging",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190619",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): : 1 have not been tolerated, or are not expected to be tolerated, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydrocodone bitartrate and acetaminophen are available in liquid form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C 18H 21NO 3 C 4H 6O 6 2½H 2O M. W. 494.490. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M. W. 151.16. Hydrocodone bitartrate and acetaminophen oral solution contains. In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring."
},
{
"NDCCode": "60687-258-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-258-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-258-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-258-44) ",
"NDC11Code": "60687-0258-71",
"ProductNDC": "60687-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Theophylline",
"NonProprietaryName": "Theophylline",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170331",
"EndMarketingDate": "20240229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091156",
"LabelerName": "American Health Packaging",
"SubstanceName": "THEOPHYLLINE ANHYDROUS",
"StrengthNumber": "80",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Methylxanthine [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170331",
"EndMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
"Description": "Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine- 2,6-dione, 3,7-dihydro-1 ,3 -dimethyl-, and is represented by the following structural formula. The molecular formula of anhydrous theophylline is C 7H 8N 4O 2 with a molecular weight of 180.17. THEOPHYLLINE ORAL SOLUTION, USP is available as a liquid intended for oral administration, containing 80 mg of theophylline anhydrous in each 15 mL (tablespoonful). THEOPHYLLINE ORAL SOLUTION, USP also contains the following inactive ingredients: citric acid, sodium saccharin, sodium benzoate, glycerin, propylene glycol, FD&C Red #40, natural and artificial fruity flavor and purified water. THEOPHYLLINE ORAL SOLUTION, USP has a pH of 4.3 – 4.7."
},
{
"NDCCode": "60687-341-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-341-71) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) ",
"NDC11Code": "60687-0341-71",
"ProductNDC": "60687-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180901",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210041",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180901",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "60687-628-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-628-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-71",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220801",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-884-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-884-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-884-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-884-44) ",
"NDC11Code": "60687-0884-71",
"ProductNDC": "60687-884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "59651-417-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (59651-417-56) ",
"NDC11Code": "59651-0417-56",
"ProductNDC": "59651-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214595",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250502",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: 0.5 mg capsular, biconvex, white, film-coated tablet debossed with ‘VA’ on one side and ‘0.5’ on the other side and a 1 mg capsular, biconvex, light blue, film-coated tablet debossed with ‘VA’ on one side and ‘1’ on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide. In addition 1 mg tablet contains FD&C Blue #2."
},
{
"NDCCode": "65643-417-06",
"PackageDescription": "180 mL in 1 BOTTLE, SPRAY (65643-417-06)",
"NDC11Code": "65643-0417-06",
"ProductNDC": "65643-417",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Desert Bambu",
"ProprietaryNameSuffix": "Tanning Spf 15",
"NonProprietaryName": "Octinoxate, Avobenzone, And Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Lifetech Resources, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTISALATE",
"StrengthNumber": "71.55; 19.08; 47.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection."
},
{
"NDCCode": "60687-266-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-266-21) / 1 TABLET in 1 BLISTER PACK (60687-266-11) ",
"NDC11Code": "60687-0266-21",
"ProductNDC": "60687-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raloxifene Hydrochloride",
"NonProprietaryName": "Raloxifene",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090842",
"LabelerName": "American Health Packaging",
"SubstanceName": "RALOXIFENE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161109",
"SamplePackage": "N",
"IndicationAndUsage": "Raloxifene hydrochloride tablet, USP is an estrogen agonist/antagonist indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women. (1.1), 2 Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2). , 3 Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3), 4 Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. (1.3).",
"Description": "Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl) ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C 28H 27NO 4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride tablets, USP are supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include mannitol, crospovidone, hydroxypropyl cellulose, poloxamer 407, magnesium stearate and opadry white (titanium Dioxide, hypromellose 2910 (3cP), hypromellose 2910 (6cP), macrogol/PEG 400 and polysorbate 80)."
},
{
"NDCCode": "60687-422-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) / 1 CAPSULE in 1 BLISTER PACK (60687-422-11) ",
"NDC11Code": "60687-0422-01",
"ProductNDC": "60687-422",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine",
"NonProprietaryName": "Amantadine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208966",
"LabelerName": "American Health Packaging",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190521",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules. : 1 Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules.",
"Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C 10H 18NCl. It has the following structural formula:. Amantadine hydrochloride is a stable white or almost white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40. The non-volatile components of imprinting ink are shellac, propylene glycol, potassium hydroxide and titanium oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "60687-648-21",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11) ",
"NDC11Code": "60687-0648-21",
"ProductNDC": "60687-648",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220211",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201785",
"LabelerName": "American Health Packaging",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220211",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt of maltodextrin premix (1:1:10), is a powder which is a off-white to pinkish brown color with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6 H-pyrazino[2,3- h][3]benzazepine, (2 R,3 R)-2,3-dihydroxybutanedioate with maltodextrin (1:1:10). It is soluble in water, practically insoluble in acetone and methylene dichloride. Varenicline tartrate has a molecular weight of 361.35 Daltons and maltodextrin, and a molecular formula of C 13H 13N 3 C 4H 6O 6 and maltodextrin. The chemical structure is:. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg circular, biconvex, white to off-white film-coated tablets, debossed with “P” on one side and “155” on other side and a 1 mg circular, biconvex, light blue film-coated tablets, debossed with “P” on one side and “156” on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid. The tablets are film-coated with a coating material containing hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake and iron oxide yellow."
},
{
"NDCCode": "60687-893-21",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (60687-893-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-893-11) ",
"NDC11Code": "60687-0893-21",
"ProductNDC": "60687-893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213019",
"LabelerName": "American Health Packaging",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is:. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6."
},
{
"NDCCode": "0264-3183-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3183-11",
"ProductNDC": "0264-3183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem And Sodium Chloride",
"NonProprietaryName": "Meropenem And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202106",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .",
"Description": "Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP)."
},
{
"NDCCode": "0264-3185-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3185-11",
"ProductNDC": "0264-3185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem And Sodium Chloride",
"NonProprietaryName": "Meropenem And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202106",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .",
"Description": "Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP)."
},
{
"NDCCode": "0440-7100-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0440-7100-30)",
"NDC11Code": "00440-7100-30",
"ProductNDC": "0440-7100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062884",
"LabelerName": "Liberty Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose and throat- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract- due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure- due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp. or E. coli. Infections of the lower respiratory tract- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections)- due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy: Amoxicillin/clarithromycin/lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or l-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). Dual Therapy: Amoxicillin/lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Indicated surgical procedures should be performed.",
"Description": "Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Amoxicillin capsules, tablets and powder for oral suspension are intended for oral administration. Amoxicillin Capsules provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Amoxicillin Capsules, USP also contain Magnesium Stearate, NF; Sodium Lauryl Sulfate, NF. The capsule shell contains D&C red No. 33; FD&C blue No. 1; FD&C red No. 40; FD&C yellow No. 6; Gelatin, NF; Sodium Lauryl Sulfate, NF Titanium Dioxide, USP. Each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Amoxicillin Tablets provide amoxicillin trihydrate equivalent to 875 mg. In addition each tablet contains the following inactive ingredients: Sodium Starch Glycolate, NF; Pregelatinized Starch, NF; Colloidal Silicon Dioxide, NF; Povidone, USP; Magnesium Stearate, NF; Polyvinyl Alcohol, USP; Titanium Dioxide, USP; Talc, NF; Polyethylene Glycol, NF and Lecithin, NF. Each tablet contains up to 0.032 mEq (0.74 mg) of Sodium. Amoxicillin for Oral Suspension is a dry powder and when reconstituted according to directions, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin per 5 mL. Amoxicillin for Oral Suspension, USP also contains flavors; casing color (FD&C red No. 40 and FD&C yellow No. 6); Microcrystalline Cellulose and Carboxymethylcellulose Sodium, NF; Colloidal Silicon Dioxide, NF; Sodium Citrate, USP; Sodium Propionate, NF; Sucrose NF. Each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium."
},
{
"NDCCode": "0525-0971-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0525-0971-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00525-0971-10",
"ProductNDC": "0525-0971",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zelnorm",
"NonProprietaryName": "Tegaserod",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021200",
"LabelerName": "Alfasigma USA, Inc.",
"SubstanceName": "TEGASEROD",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].",
"Description": "ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate."
},
{
"NDCCode": "0525-0971-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0525-0971-30) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00525-0971-30",
"ProductNDC": "0525-0971",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zelnorm",
"NonProprietaryName": "Tegaserod",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021200",
"LabelerName": "Alfasigma USA, Inc.",
"SubstanceName": "TEGASEROD",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].",
"Description": "ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate."
},
{
"NDCCode": "0525-0971-60",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0525-0971-60) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00525-0971-60",
"ProductNDC": "0525-0971",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zelnorm",
"NonProprietaryName": "Tegaserod",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021200",
"LabelerName": "Alfasigma USA, Inc.",
"SubstanceName": "TEGASEROD",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].",
"Description": "ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate."
},
{
"NDCCode": "0924-5605-01",
"PackageDescription": ".5 g in 1 PACKET (0924-5605-01) ",
"NDC11Code": "00924-5605-01",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "0924-5605-02",
"PackageDescription": "6 PACKET in 1 BAG (0924-5605-02) > .5 g in 1 PACKET",
"NDC11Code": "00924-5605-02",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "0924-5605-03",
"PackageDescription": "10 PACKET in 1 CARTON (0924-5605-03) > .5 g in 1 PACKET",
"NDC11Code": "00924-5605-03",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "0924-5605-04",
"PackageDescription": "12 PACKET in 1 CARTON (0924-5605-04) > .5 g in 1 PACKET",
"NDC11Code": "00924-5605-04",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "0924-5605-05",
"PackageDescription": "25 PACKET in 1 BOX, UNIT-DOSE (0924-5605-05) > .5 g in 1 PACKET",
"NDC11Code": "00924-5605-05",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "0924-5605-06",
"PackageDescription": "60 PACKET in 1 CARTON (0924-5605-06) > .5 g in 1 PACKET",
"NDC11Code": "00924-5605-06",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "0924-5605-07",
"PackageDescription": "144 PACKET in 1 BOX, UNIT-DOSE (0924-5605-07) > .5 g in 1 PACKET",
"NDC11Code": "00924-5605-07",
"ProductNDC": "0924-5605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Acme united Corporation",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "417.8; 3.5; 5322.8",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191112",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in minor cuts scrapes burns."
},
{
"NDCCode": "10812-417-01",
"PackageDescription": "184 g in 1 CAN (10812-417-01)",
"NDC11Code": "10812-0417-01",
"ProductNDC": "10812-417",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Beach Defense Water Plus Sun Protection",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120601",
"EndMarketingDate": "20190215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 30; 40; 20; 50",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-02-16",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "10889-417-02",
"PackageDescription": "64 g in 1 APPLICATOR (10889-417-02) ",
"NDC11Code": "10889-0417-02",
"ProductNDC": "10889-417",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scent-a-way Odor Control",
"NonProprietaryName": "Aluminum Zirconium Trichlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"EndMarketingDate": "20181231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "VVF Kansas Services LLC",
"SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
"StrengthNumber": "12.8",
"StrengthUnit": "g/64g",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120301",
"EndMarketingDatePackage": "20181231",
"SamplePackage": "N"
},
{
"NDCCode": "11673-417-01",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (11673-417-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11673-0417-01",
"ProductNDC": "11673-417",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Sinus And Cold D",
"NonProprietaryName": "Naproxen Sodium, Pseudoephedrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076518",
"LabelerName": "Target Corporation",
"SubstanceName": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "220; 120",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130830",
"SamplePackage": "N"
},
{
"NDCCode": "13537-417-16",
"PackageDescription": "1 TUBE in 1 BOX (13537-417-16) > 4 g in 1 TUBE (13537-417-15)",
"NDC11Code": "13537-0417-16",
"ProductNDC": "13537-417",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Couleur Luxe Rouge Amplifier Xp Amplifying Spf 15",
"ProprietaryNameSuffix": "(rose Damour) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140127",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".047; .009",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-417-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (16714-417-01)",
"NDC11Code": "16714-0417-01",
"ProductNDC": "16714-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
"ProprietaryNameSuffix": "50 Mg-25 Mg",
"NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202870",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "16714-417-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-417-02)",
"NDC11Code": "16714-0417-02",
"ProductNDC": "16714-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
"ProprietaryNameSuffix": "50 Mg-25 Mg",
"NonProprietaryName": "Metoprolol Tartrate And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202870",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>60687-417-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-417-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-417-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-417-44) </PackageDescription>
<NDC11Code>60687-0417-71</NDC11Code>
<ProductNDC>60687-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211023</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): : 1 have not been tolerated, or are not expected to be tolerated, 2 have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen are available in liquid form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C 18H 21NO 3 C 4H 6O 6 2½H 2O M. W. 494.490. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non- salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M. W. 151.16. Hydrocodone bitartrate and acetaminophen oral solution contains. In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.</Description>
</NDC>
<NDC>
<NDCCode>60687-258-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-258-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-258-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-258-44) </PackageDescription>
<NDC11Code>60687-0258-71</NDC11Code>
<ProductNDC>60687-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Theophylline</ProprietaryName>
<NonProprietaryName>Theophylline</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170331</StartMarketingDate>
<EndMarketingDate>20240229</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091156</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>THEOPHYLLINE ANHYDROUS</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<EndMarketingDatePackage>20240229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
<Description>Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine- 2,6-dione, 3,7-dihydro-1 ,3 -dimethyl-, and is represented by the following structural formula. The molecular formula of anhydrous theophylline is C 7H 8N 4O 2 with a molecular weight of 180.17. THEOPHYLLINE ORAL SOLUTION, USP is available as a liquid intended for oral administration, containing 80 mg of theophylline anhydrous in each 15 mL (tablespoonful). THEOPHYLLINE ORAL SOLUTION, USP also contains the following inactive ingredients: citric acid, sodium saccharin, sodium benzoate, glycerin, propylene glycol, FD&C Red #40, natural and artificial fruity flavor and purified water. THEOPHYLLINE ORAL SOLUTION, USP has a pH of 4.3 – 4.7.</Description>
</NDC>
<NDC>
<NDCCode>60687-341-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-341-71) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) </PackageDescription>
<NDC11Code>60687-0341-71</NDC11Code>
<ProductNDC>60687-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180901</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210041</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180901</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-628-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-628-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-71</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-884-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-884-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-884-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-884-44) </PackageDescription>
<NDC11Code>60687-0884-71</NDC11Code>
<ProductNDC>60687-884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>59651-417-56</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (59651-417-56) </PackageDescription>
<NDC11Code>59651-0417-56</NDC11Code>
<ProductNDC>59651-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214595</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: 0.5 mg capsular, biconvex, white, film-coated tablet debossed with ‘VA’ on one side and ‘0.5’ on the other side and a 1 mg capsular, biconvex, light blue, film-coated tablet debossed with ‘VA’ on one side and ‘1’ on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide. In addition 1 mg tablet contains FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>65643-417-06</NDCCode>
<PackageDescription>180 mL in 1 BOTTLE, SPRAY (65643-417-06)</PackageDescription>
<NDC11Code>65643-0417-06</NDC11Code>
<ProductNDC>65643-417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Desert Bambu</ProprietaryName>
<ProprietaryNameSuffix>Tanning Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Avobenzone, And Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Lifetech Resources, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTISALATE</SubstanceName>
<StrengthNumber>71.55; 19.08; 47.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60687-266-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-266-21) / 1 TABLET in 1 BLISTER PACK (60687-266-11) </PackageDescription>
<NDC11Code>60687-0266-21</NDC11Code>
<ProductNDC>60687-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raloxifene Hydrochloride</ProprietaryName>
<NonProprietaryName>Raloxifene</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090842</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Raloxifene hydrochloride tablet, USP is an estrogen agonist/antagonist indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women. (1.1), 2 Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2). , 3 Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3), 4 Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. (1.3).</IndicationAndUsage>
<Description>Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl) ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C 28H 27NO 4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride tablets, USP are supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include mannitol, crospovidone, hydroxypropyl cellulose, poloxamer 407, magnesium stearate and opadry white (titanium Dioxide, hypromellose 2910 (3cP), hypromellose 2910 (6cP), macrogol/PEG 400 and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>60687-422-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) / 1 CAPSULE in 1 BLISTER PACK (60687-422-11) </PackageDescription>
<NDC11Code>60687-0422-01</NDC11Code>
<ProductNDC>60687-422</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208966</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules. : 1 Amantadine hydrochloride capsules are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules.</IndicationAndUsage>
<Description>Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C 10H 18NCl. It has the following structural formula:. Amantadine hydrochloride is a stable white or almost white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40. The non-volatile components of imprinting ink are shellac, propylene glycol, potassium hydroxide and titanium oxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>60687-648-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11) </PackageDescription>
<NDC11Code>60687-0648-21</NDC11Code>
<ProductNDC>60687-648</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220211</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201785</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220211</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt of maltodextrin premix (1:1:10), is a powder which is a off-white to pinkish brown color with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6 H-pyrazino[2,3- h][3]benzazepine, (2 R,3 R)-2,3-dihydroxybutanedioate with maltodextrin (1:1:10). It is soluble in water, practically insoluble in acetone and methylene dichloride. Varenicline tartrate has a molecular weight of 361.35 Daltons and maltodextrin, and a molecular formula of C 13H 13N 3 C 4H 6O 6 and maltodextrin. The chemical structure is:. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg circular, biconvex, white to off-white film-coated tablets, debossed with “P” on one side and “155” on other side and a 1 mg circular, biconvex, light blue film-coated tablets, debossed with “P” on one side and “156” on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid. The tablets are film-coated with a coating material containing hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>60687-893-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (60687-893-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-893-11) </PackageDescription>
<NDC11Code>60687-0893-21</NDC11Code>
<ProductNDC>60687-893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213019</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is off-white to light fawn powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and slightly soluble in N, N-dimethyl Formamide. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is:. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg off-white, capsule shaped, biconvex, film-coated tablets, debossed with ‘V1’ on one side and plain on other side and a 1 mg blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘V2’ on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, maltodextrin. The film coating contains hypromellose, titanium dioxide, polyethylene glycol. 1 mg has FD&C Blue # 2 and FD&C yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>0264-3183-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3183-11</NDC11Code>
<ProductNDC>0264-3183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Meropenem And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202106</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .</IndicationAndUsage>
<Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).</Description>
</NDC>
<NDC>
<NDCCode>0264-3185-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3185-11</NDC11Code>
<ProductNDC>0264-3185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Meropenem And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202106</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .</IndicationAndUsage>
<Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).</Description>
</NDC>
<NDC>
<NDCCode>0440-7100-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0440-7100-30)</PackageDescription>
<NDC11Code>00440-7100-30</NDC11Code>
<ProductNDC>0440-7100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062884</ApplicationNumber>
<LabelerName>Liberty Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose and throat- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract- due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure- due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp. or E. coli. Infections of the lower respiratory tract- due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections)- due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy: Amoxicillin/clarithromycin/lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or l-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). Dual Therapy: Amoxicillin/lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S 3H2O, and the molecular weight is 419.45. Amoxicillin capsules, tablets and powder for oral suspension are intended for oral administration. Amoxicillin Capsules provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Amoxicillin Capsules, USP also contain Magnesium Stearate, NF; Sodium Lauryl Sulfate, NF. The capsule shell contains D&C red No. 33; FD&C blue No. 1; FD&C red No. 40; FD&C yellow No. 6; Gelatin, NF; Sodium Lauryl Sulfate, NF Titanium Dioxide, USP. Each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Amoxicillin Tablets provide amoxicillin trihydrate equivalent to 875 mg. In addition each tablet contains the following inactive ingredients: Sodium Starch Glycolate, NF; Pregelatinized Starch, NF; Colloidal Silicon Dioxide, NF; Povidone, USP; Magnesium Stearate, NF; Polyvinyl Alcohol, USP; Titanium Dioxide, USP; Talc, NF; Polyethylene Glycol, NF and Lecithin, NF. Each tablet contains up to 0.032 mEq (0.74 mg) of Sodium. Amoxicillin for Oral Suspension is a dry powder and when reconstituted according to directions, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin per 5 mL. Amoxicillin for Oral Suspension, USP also contains flavors; casing color (FD&C red No. 40 and FD&C yellow No. 6); Microcrystalline Cellulose and Carboxymethylcellulose Sodium, NF; Colloidal Silicon Dioxide, NF; Sodium Citrate, USP; Sodium Propionate, NF; Sucrose NF. Each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>0525-0971-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0525-0971-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00525-0971-10</NDC11Code>
<ProductNDC>0525-0971</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zelnorm</ProprietaryName>
<NonProprietaryName>Tegaserod</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021200</ApplicationNumber>
<LabelerName>Alfasigma USA, Inc.</LabelerName>
<SubstanceName>TEGASEROD</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>0525-0971-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0525-0971-30) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00525-0971-30</NDC11Code>
<ProductNDC>0525-0971</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zelnorm</ProprietaryName>
<NonProprietaryName>Tegaserod</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021200</ApplicationNumber>
<LabelerName>Alfasigma USA, Inc.</LabelerName>
<SubstanceName>TEGASEROD</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>0525-0971-60</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0525-0971-60) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00525-0971-60</NDC11Code>
<ProductNDC>0525-0971</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zelnorm</ProprietaryName>
<NonProprietaryName>Tegaserod</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021200</ApplicationNumber>
<LabelerName>Alfasigma USA, Inc.</LabelerName>
<SubstanceName>TEGASEROD</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA],Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use: 1 The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT4) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5OC4H4O4. The molecular weight is 417.47 and the structural formula is. Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each ZELNORM tablet contains 6 mg of tegaserod (equivalent to 8.31 mg of tegaserod maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, hypromellose, and lactose monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>0924-5605-01</NDCCode>
<PackageDescription>.5 g in 1 PACKET (0924-5605-01) </PackageDescription>
<NDC11Code>00924-5605-01</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5605-02</NDCCode>
<PackageDescription>6 PACKET in 1 BAG (0924-5605-02) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5605-02</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5605-03</NDCCode>
<PackageDescription>10 PACKET in 1 CARTON (0924-5605-03) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5605-03</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5605-04</NDCCode>
<PackageDescription>12 PACKET in 1 CARTON (0924-5605-04) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5605-04</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5605-05</NDCCode>
<PackageDescription>25 PACKET in 1 BOX, UNIT-DOSE (0924-5605-05) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5605-05</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5605-06</NDCCode>
<PackageDescription>60 PACKET in 1 CARTON (0924-5605-06) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5605-06</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5605-07</NDCCode>
<PackageDescription>144 PACKET in 1 BOX, UNIT-DOSE (0924-5605-07) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5605-07</NDC11Code>
<ProductNDC>0924-5605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Acme united Corporation</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>417.8; 3.5; 5322.8</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in minor cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10812-417-01</NDCCode>
<PackageDescription>184 g in 1 CAN (10812-417-01)</PackageDescription>
<NDC11Code>10812-0417-01</NDC11Code>
<ProductNDC>10812-417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Beach Defense Water Plus Sun Protection</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<EndMarketingDate>20190215</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 30; 40; 20; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>10889-417-02</NDCCode>
<PackageDescription>64 g in 1 APPLICATOR (10889-417-02) </PackageDescription>
<NDC11Code>10889-0417-02</NDC11Code>
<ProductNDC>10889-417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scent-a-way Odor Control</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Trichlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<EndMarketingDate>20181231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>VVF Kansas Services LLC</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>12.8</StrengthNumber>
<StrengthUnit>g/64g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120301</StartMarketingDatePackage>
<EndMarketingDatePackage>20181231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-417-01</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (11673-417-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0417-01</NDC11Code>
<ProductNDC>11673-417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Sinus And Cold D</ProprietaryName>
<NonProprietaryName>Naproxen Sodium, Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076518</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>220; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-417-16</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-417-16) > 4 g in 1 TUBE (13537-417-15)</PackageDescription>
<NDC11Code>13537-0417-16</NDC11Code>
<ProductNDC>13537-417</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Couleur Luxe Rouge Amplifier Xp Amplifying Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(rose Damour) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.047; .009</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-417-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16714-417-01)</PackageDescription>
<NDC11Code>16714-0417-01</NDC11Code>
<ProductNDC>16714-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate And Hydrochlorothiazide</ProprietaryName>
<ProprietaryNameSuffix>50 Mg-25 Mg</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Tartrate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202870</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16714-417-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-417-02)</PackageDescription>
<NDC11Code>16714-0417-02</NDC11Code>
<ProductNDC>16714-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate And Hydrochlorothiazide</ProprietaryName>
<ProprietaryNameSuffix>50 Mg-25 Mg</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Tartrate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202870</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>