{
"NDC": [
{
"NDCCode": "53002-4251-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-4251-3) ",
"NDC11Code": "53002-4251-03",
"ProductNDC": "53002-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050114",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077095",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
},
{
"NDCCode": "53002-4251-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (53002-4251-0) ",
"NDC11Code": "53002-4251-00",
"ProductNDC": "53002-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050114",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077095",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
},
{
"NDCCode": "53002-4251-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (53002-4251-6) ",
"NDC11Code": "53002-4251-06",
"ProductNDC": "53002-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050114",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077095",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
},
{
"NDCCode": "0498-4251-01",
"PackageDescription": "1 KIT in 1 KIT (0498-4251-01) * 2 TABLET in 1 PACKET (0498-0114-01) * .4 mL in 1 POUCH (0498-0733-00) * .3 mL in 1 AMPULE (0498-3334-00) * .4 mL in 1 POUCH (0498-0143-04) * .9 g in 1 PACKET",
"NDC11Code": "00498-4251-01",
"ProductNDC": "0498-4251",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4251 First Aid Kit",
"NonProprietaryName": "4251 First Aid Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20181018",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Honeywell Safety Products USA, INC",
"Status": "Deprecated",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181018",
"SamplePackage": "N"
},
{
"NDCCode": "54868-4251-1",
"PackageDescription": "3 TABLET in 1 BOTTLE (54868-4251-1)",
"NDC11Code": "54868-4251-01",
"ProductNDC": "54868-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxalt",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020864",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.",
"Description": "MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor."
},
{
"NDCCode": "54868-4251-3",
"PackageDescription": "6 TABLET in 1 BOTTLE (54868-4251-3)",
"NDC11Code": "54868-4251-03",
"ProductNDC": "54868-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxalt",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020864",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.",
"Description": "MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor."
},
{
"NDCCode": "63629-4251-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (63629-4251-3) ",
"NDC11Code": "63629-4251-03",
"ProductNDC": "63629-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100513",
"SamplePackage": "N"
},
{
"NDCCode": "67684-4251-3",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4251-03",
"ProductNDC": "67684-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2."
},
{
"NDCCode": "68071-4251-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-4251-3) ",
"NDC11Code": "68071-4251-03",
"ProductNDC": "68071-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078925",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180124",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension ( 1.1) : 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate."
},
{
"NDCCode": "50090-4251-0",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50090-4251-0) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50090-4251-00",
"ProductNDC": "50090-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20171128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077235",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone acetate is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone acetate long-term [see Warnings and Precautions (5.1)].",
"Description": "Medroxyprogesterone acetate contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α-). The structural formula is as follows. Medroxyprogesterone acetate for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both."
},
{
"NDCCode": "54868-4251-0",
"PackageDescription": "9 TABLET in 1 BOTTLE (54868-4251-0)",
"NDC11Code": "54868-4251-00",
"ProductNDC": "54868-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxalt",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020864",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.",
"Description": "MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor."
},
{
"NDCCode": "54868-4251-2",
"PackageDescription": "12 POUCH in 1 CARTON (54868-4251-2) > 1 TABLET in 1 POUCH",
"NDC11Code": "54868-4251-02",
"ProductNDC": "54868-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maxalt",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020864",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.",
"Description": "MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor."
},
{
"NDCCode": "53002-0060-3",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (53002-0060-3) ",
"NDC11Code": "53002-0060-03",
"ProductNDC": "53002-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201506",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2."
},
{
"NDCCode": "53002-0061-3",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (53002-0061-3) ",
"NDC11Code": "53002-0061-03",
"ProductNDC": "53002-0061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "53002-0062-3",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (53002-0062-3) ",
"NDC11Code": "53002-0062-03",
"ProductNDC": "53002-0062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203047",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2."
},
{
"NDCCode": "53002-0080-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (53002-0080-3) ",
"NDC11Code": "53002-0080-03",
"ProductNDC": "53002-0080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202168",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2021-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N"
},
{
"NDCCode": "53002-0081-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (53002-0081-3) ",
"NDC11Code": "53002-0081-03",
"ProductNDC": "53002-0081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202168",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2021-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "53002-0082-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (53002-0082-3) ",
"NDC11Code": "53002-0082-03",
"ProductNDC": "53002-0082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "53002-0083-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (53002-0083-3) ",
"NDC11Code": "53002-0083-03",
"ProductNDC": "53002-0083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210401",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Capsules, USP and Acyclovir Tablets, USP are formulations for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. Printed with edible black ink. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Acyclovir, USP is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37℃ is 2.5mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL. Drug Resistance. Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "53002-0084-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (53002-0084-3) ",
"NDC11Code": "53002-0084-03",
"ProductNDC": "53002-0084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209366",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula."
},
{
"NDCCode": "53002-0085-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (53002-0085-3) ",
"NDC11Code": "53002-0085-03",
"ProductNDC": "53002-0085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203834",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:."
},
{
"NDCCode": "53002-0101-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-0101-3) ",
"NDC11Code": "53002-0101-03",
"ProductNDC": "53002-0101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040779",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). : 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia, .",
"Description": "Acetaminophen and codeine phosphate tablets, USP are supplied in tablet form for oral administration. 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:. Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/30 mg) contains. Acetaminophen .................................................. 300 mg Codeine Phosphate .............................................. 30 mg. In addition, each acetaminophen and codeine phosphate tablet, USP contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid."
},
{
"NDCCode": "53002-0102-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-0102-3) ",
"NDC11Code": "53002-0102-03",
"ProductNDC": "53002-0102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040419",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. 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. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "53002-0156-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-0156-3) ",
"NDC11Code": "53002-0156-03",
"ProductNDC": "53002-0156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040655",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "53002-0270-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0270-3) ",
"NDC11Code": "53002-0270-03",
"ProductNDC": "53002-0270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203834",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:."
},
{
"NDCCode": "53002-0271-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0271-3) ",
"NDC11Code": "53002-0271-03",
"ProductNDC": "53002-0271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "53002-0272-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (53002-0272-3) ",
"NDC11Code": "53002-0272-03",
"ProductNDC": "53002-0272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209366",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula."
},
{
"NDCCode": "53002-0340-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-0340-3) ",
"NDC11Code": "53002-0340-03",
"ProductNDC": "53002-0340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19811016",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018276",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam is indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Inactive ingredients: cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2."
},
{
"NDCCode": "53002-0341-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-0341-3) ",
"NDC11Code": "53002-0341-03",
"ProductNDC": "53002-0341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180709",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207507",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam Tablets, USP, contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Alprazolam Tablets, USP, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake."
},
{
"NDCCode": "53002-0410-3",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (53002-0410-3) ",
"NDC11Code": "53002-0410-03",
"ProductNDC": "53002-0410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040749",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N"
}
]
}
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-4251-3) </PackageDescription>
<NDC11Code>53002-4251-03</NDC11Code>
<ProductNDC>53002-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050114</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077095</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>53002-4251-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (53002-4251-0) </PackageDescription>
<NDC11Code>53002-4251-00</NDC11Code>
<ProductNDC>53002-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<EndMarketingDate>20241231</EndMarketingDate>
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<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>53002-4251-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (53002-4251-6) </PackageDescription>
<NDC11Code>53002-4251-06</NDC11Code>
<ProductNDC>53002-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<EndMarketingDate>20241231</EndMarketingDate>
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<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0498-4251-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0498-4251-01) * 2 TABLET in 1 PACKET (0498-0114-01) * .4 mL in 1 POUCH (0498-0733-00) * .3 mL in 1 AMPULE (0498-3334-00) * .4 mL in 1 POUCH (0498-0143-04) * .9 g in 1 PACKET</PackageDescription>
<NDC11Code>00498-4251-01</NDC11Code>
<ProductNDC>0498-4251</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4251 First Aid Kit</ProprietaryName>
<NonProprietaryName>4251 First Aid Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181018</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Honeywell Safety Products USA, INC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>54868-4251-1</NDCCode>
<PackageDescription>3 TABLET in 1 BOTTLE (54868-4251-1)</PackageDescription>
<NDC11Code>54868-4251-01</NDC11Code>
<ProductNDC>54868-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxalt</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020864</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.</IndicationAndUsage>
<Description>MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.</Description>
</NDC>
<NDC>
<NDCCode>54868-4251-3</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE (54868-4251-3)</PackageDescription>
<NDC11Code>54868-4251-03</NDC11Code>
<ProductNDC>54868-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxalt</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020864</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.</IndicationAndUsage>
<Description>MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.</Description>
</NDC>
<NDC>
<NDCCode>63629-4251-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63629-4251-3) </PackageDescription>
<NDC11Code>63629-4251-03</NDC11Code>
<ProductNDC>63629-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.137</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67684-4251-3</NDCCode>
<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>67684-4251-03</NDC11Code>
<ProductNDC>67684-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues),, 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>ELUCIREM (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>68071-4251-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-4251-3) </PackageDescription>
<NDC11Code>68071-4251-03</NDC11Code>
<ProductNDC>68071-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078925</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension ( 1.1) : 1 Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl(±)-2- [(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6- methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50090-4251-0</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50090-4251-0) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50090-4251-00</NDC11Code>
<ProductNDC>50090-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20171128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077235</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone acetate is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone acetate long-term [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Medroxyprogesterone acetate contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α-). The structural formula is as follows. Medroxyprogesterone acetate for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.</Description>
</NDC>
<NDC>
<NDCCode>54868-4251-0</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE (54868-4251-0)</PackageDescription>
<NDC11Code>54868-4251-00</NDC11Code>
<ProductNDC>54868-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxalt</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020864</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.</IndicationAndUsage>
<Description>MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.</Description>
</NDC>
<NDC>
<NDCCode>54868-4251-2</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (54868-4251-2) > 1 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>54868-4251-02</NDC11Code>
<ProductNDC>54868-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maxalt</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020864</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks., 2 MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]., 3 MAXALT is not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of MAXALT have not been established for cluster headache.</IndicationAndUsage>
<Description>MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.</Description>
</NDC>
<NDC>
<NDCCode>53002-0060-3</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (53002-0060-3) </PackageDescription>
<NDC11Code>53002-0060-03</NDC11Code>
<ProductNDC>53002-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201506</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0061-3</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (53002-0061-3) </PackageDescription>
<NDC11Code>53002-0061-03</NDC11Code>
<ProductNDC>53002-0061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>53002-0062-3</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (53002-0062-3) </PackageDescription>
<NDC11Code>53002-0062-03</NDC11Code>
<ProductNDC>53002-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203047</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0080-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (53002-0080-3) </PackageDescription>
<NDC11Code>53002-0080-03</NDC11Code>
<ProductNDC>53002-0080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202168</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-0081-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (53002-0081-3) </PackageDescription>
<NDC11Code>53002-0081-03</NDC11Code>
<ProductNDC>53002-0081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202168</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-0082-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (53002-0082-3) </PackageDescription>
<NDC11Code>53002-0082-03</NDC11Code>
<ProductNDC>53002-0082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0083-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (53002-0083-3) </PackageDescription>
<NDC11Code>53002-0083-03</NDC11Code>
<ProductNDC>53002-0083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210401</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections. Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox. Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Capsules, USP and Acyclovir Tablets, USP are formulations for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. Printed with edible black ink. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Acyclovir, USP is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37℃ is 2.5mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities. The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL. Drug Resistance. Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>53002-0084-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (53002-0084-3) </PackageDescription>
<NDC11Code>53002-0084-03</NDC11Code>
<ProductNDC>53002-0084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209366</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>53002-0085-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (53002-0085-3) </PackageDescription>
<NDC11Code>53002-0085-03</NDC11Code>
<ProductNDC>53002-0085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203834</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0101-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-0101-3) </PackageDescription>
<NDC11Code>53002-0101-03</NDC11Code>
<ProductNDC>53002-0101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040779</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). : 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia, .</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets, USP are supplied in tablet form for oral administration. 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:. Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:. Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/30 mg) contains. Acetaminophen .................................................. 300 mg Codeine Phosphate .............................................. 30 mg. In addition, each acetaminophen and codeine phosphate tablet, USP contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>53002-0102-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-0102-3) </PackageDescription>
<NDC11Code>53002-0102-03</NDC11Code>
<ProductNDC>53002-0102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040419</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. 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. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>53002-0156-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-0156-3) </PackageDescription>
<NDC11Code>53002-0156-03</NDC11Code>
<ProductNDC>53002-0156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040655</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-0270-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0270-3) </PackageDescription>
<NDC11Code>53002-0270-03</NDC11Code>
<ProductNDC>53002-0270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203834</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0271-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0271-3) </PackageDescription>
<NDC11Code>53002-0271-03</NDC11Code>
<ProductNDC>53002-0271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0272-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (53002-0272-3) </PackageDescription>
<NDC11Code>53002-0272-03</NDC11Code>
<ProductNDC>53002-0272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209366</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>53002-0340-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-0340-3) </PackageDescription>
<NDC11Code>53002-0340-03</NDC11Code>
<ProductNDC>53002-0340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19811016</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018276</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam is indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Inactive ingredients: cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0341-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (53002-0341-3) </PackageDescription>
<NDC11Code>53002-0341-03</NDC11Code>
<ProductNDC>53002-0341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180709</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207507</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam Tablets, USP, contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Alprazolam Tablets, USP, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>53002-0410-3</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (53002-0410-3) </PackageDescription>
<NDC11Code>53002-0410-03</NDC11Code>
<ProductNDC>53002-0410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040749</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>