{
"NDC": [
{
"NDCCode": "71334-215-50",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (71334-215-50) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-14) ",
"NDC11Code": "71334-0215-50",
"ProductNDC": "71334-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"SubstanceName": "MITAPIVAT",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "71334-230-13",
"PackageDescription": "1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) ",
"NDC11Code": "71334-0230-13",
"ProductNDC": "71334-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "KIT",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "71334-205-05",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14) ",
"NDC11Code": "71334-0205-05",
"ProductNDC": "71334-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"SubstanceName": "MITAPIVAT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "71334-210-20",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (71334-210-20) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-14) ",
"NDC11Code": "71334-0210-20",
"ProductNDC": "71334-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"SubstanceName": "MITAPIVAT",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "71334-220-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (71334-220-11) / 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "71334-0220-11",
"ProductNDC": "71334-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"SubstanceName": "MITAPIVAT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "71334-225-12",
"PackageDescription": "1 KIT in 1 CARTON (71334-225-12) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-07) ",
"NDC11Code": "71334-0225-12",
"ProductNDC": "71334-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "KIT",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "16729-215-11",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (16729-215-11) ",
"NDC11Code": "16729-0215-11",
"ProductNDC": "16729-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202825",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide."
},
{
"NDCCode": "25021-215-98",
"PackageDescription": "1 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE",
"NDC11Code": "25021-0215-98",
"ProductNDC": "25021-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorouracil",
"NonProprietaryName": "Fluorouracil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203609",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160915",
"SamplePackage": "N",
"IndicationAndUsage": "Fluorouracil Injection is indicated for the treatment of patients with:.",
"Description": "Fluorouracil Injection, USP, a nucleoside metabolic inhibitor, is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in a pharmacy bulk package, a sterile preparation that contains doses for multiple patients for intravenous administration. Each mL contains 50 mg fluorouracil in water for injection, USP. The pH is adjusted to approximately 9.2 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is:. Molecular formula: C4H3FN2O2. Molecular weight: 130.08 g/mole."
},
{
"NDCCode": "42582-215-05",
"PackageDescription": "50 TABLET, COATED in 1 BOTTLE (42582-215-05) ",
"NDC11Code": "42582-0215-05",
"ProductNDC": "42582-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211343",
"LabelerName": "Bi-Coastal Pharma International, LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200528",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets, USP. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8 ∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients for the tablet formulation are: croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose PH112, polyethylene glycol, silicon dioxide, titanium dioxide and water. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42961-215-02",
"PackageDescription": "50 PACKAGE in 1 BOX (42961-215-02) > 5.8 mg in 1 PACKAGE",
"NDC11Code": "42961-0215-02",
"ProductNDC": "42961-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xpect Cherry Menthol Cough Drop",
"NonProprietaryName": "Cherry Menthol Cough Drop",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20220128",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Cintas Corp",
"SubstanceName": "MENTHOL",
"StrengthNumber": "5.8",
"StrengthUnit": "mg/mg",
"Status": "Deprecated",
"LastUpdate": "2023-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220128",
"SamplePackage": "N"
},
{
"NDCCode": "47993-215-04",
"PackageDescription": "50 g in 1 BOTTLE (47993-215-04)",
"NDC11Code": "47993-0215-04",
"ProductNDC": "47993-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Block Sprary",
"NonProprietaryName": "Sun Block Sprary Spf15",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150220",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
"SubstanceName": "HOMOSALATE; OCTINOXATE",
"StrengthNumber": "3; 6",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions. Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry."
},
{
"NDCCode": "64220-215-09",
"PackageDescription": "50 kg in 1 DRUM (64220-215-09) ",
"NDC11Code": "64220-0215-09",
"ProductNDC": "64220-215",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Empagliflozin (process Ii)",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230401",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "EMPAGLIFLOZIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-04-27",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-APR-23"
},
{
"NDCCode": "66326-215-04",
"PackageDescription": "50 kg in 1 DRUM (66326-215-04) ",
"NDC11Code": "66326-0215-04",
"ProductNDC": "66326-215",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20200104",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Sri Krishna Pharmaceuticals Ltd. Unit 1",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "950",
"StrengthUnit": "g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "04-JAN-20"
},
{
"NDCCode": "67457-215-01",
"PackageDescription": "1 KIT in 1 CARTON (67457-215-01) * 10 mL in 1 VIAL, GLASS (67457-213-50) * 10 mL in 1 VIAL, GLASS (67457-214-10) ",
"NDC11Code": "67457-0215-01",
"ProductNDC": "67457-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melphalan Hydrochloride",
"NonProprietaryName": "Melphalan Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20130110",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090270",
"LabelerName": "Mylan Institutional LLC",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130110",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.",
"Description": "Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or Lsarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the Lisomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of ~ 2.5. Melphalan Hydrochloride for Injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and the inactive ingredient povidone 20 mg. Melphalan Hydrochloride for Injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan Hydrochloride for Injection is administered intravenously."
},
{
"NDCCode": "68828-215-02",
"PackageDescription": "1 TUBE in 1 CARTON (68828-215-02) > 50 mL in 1 TUBE (68828-215-01) ",
"NDC11Code": "68828-0215-02",
"ProductNDC": "68828-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oil-free Facial Sunscreen Spectrum Spf 50",
"ProprietaryNameSuffix": "Jafra",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150213",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "JAFRA COSMETICS INTERNATIONAL",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 7",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150213",
"SamplePackage": "N"
},
{
"NDCCode": "70860-215-68",
"PackageDescription": "1 VIAL in 1 CARTON (70860-215-68) / 50 mL in 1 VIAL",
"NDC11Code": "70860-0215-68",
"ProductNDC": "70860-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191130",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207326",
"LabelerName": "Athenex Pharmaceutical Division, LLC.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191130",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.",
"Description": "Paclitaxel Injection, USP is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multi-dose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of Polyoxyl 35 Castor Oil, NF, 49.7% (v/v) Dehydrated Alcohol, USP and 2 mg Citric Acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media ‘Hicksii'. The chemical name for paclitaxel is (2a R,4 S,4a S,6 R,9 S,11 S,12 S,12a R,12b S)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4,6,9,11,12,-12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5 H-cyclodeca [3,4] benz [1,2-b] oxet-5-one 6,12b-diacetate, 12-benzoate, 9-ester with (2 R,3 S) -N-benzoyl-3-phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216° to 217°C."
},
{
"NDCCode": "71919-215-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-215-09) ",
"NDC11Code": "71919-0215-09",
"ProductNDC": "71919-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cochlearia Officinalis",
"NonProprietaryName": "Cochlearia Officinalis Flowering Top",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "COCHLEARIA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131212",
"SamplePackage": "N",
"IndicationAndUsage": "Indications:. COCHLEARIA OFF Radiating stomach pains."
},
{
"NDCCode": "71921-215-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (71921-215-50) ",
"NDC11Code": "71921-0215-50",
"ProductNDC": "71921-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202112",
"LabelerName": "Florida Pharmaceutical Products, LLC",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride tablets USP is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish- white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. Glimepiride tablets USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, polysorbate 80, sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red and glimepiride 2 mg tablets contain Ferric Oxide Yellow."
},
{
"NDCCode": "72415-215-50",
"PackageDescription": "100 g in 1 TUBE (72415-215-50) ",
"NDC11Code": "72415-0215-50",
"ProductNDC": "72415-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Caredo Repair Cracked Teeth Toothpastes",
"ProprietaryNameSuffix": "100g",
"NonProprietaryName": "Repair Cracked Teeth Toothpaste",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20180703",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hong Kong Prosthodontics Medicine Limited",
"SubstanceName": "GLYCINE",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180703",
"SamplePackage": "N",
"IndicationAndUsage": "Apply properly this product on the toothbrush, and brush tooth as like common do."
},
{
"NDCCode": "83872-215-01",
"PackageDescription": "50 g in 1 BOTTLE (83872-215-01) ",
"NDC11Code": "83872-0215-01",
"ProductNDC": "83872-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Druggist Dark Spot Corrwxtor Lntimate Area",
"NonProprietaryName": "Dark Spot Corrwxtor Lntimate Area",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240306",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Shenzhen Xiaomai Manufacturing Co., Ltd.",
"SubstanceName": "4-BUTYLRESORCINOL; ARBUTIN; NIACINAMIDE",
"StrengthNumber": "5; 70; 30",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240306",
"SamplePackage": "N",
"IndicationAndUsage": "Lighten skin spots, even skin tone, and make skin brighter.",
"Description": "Do not use on damaged or broken skin."
},
{
"NDCCode": "84347-215-50",
"PackageDescription": "50 g in 1 BOTTLE (84347-215-50) ",
"NDC11Code": "84347-0215-50",
"ProductNDC": "84347-215",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Thymosin Beta-4 Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Shenzhen Alvantis Pharma Co., Ltd.",
"SubstanceName": "THYMOSIN .BETA.-4",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-09-03",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-SEP-26"
},
{
"NDCCode": "84522-215-01",
"PackageDescription": "50 mL in 1 BOX (84522-215-01) ",
"NDC11Code": "84522-0215-01",
"ProductNDC": "84522-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hair Growth Sevim",
"NonProprietaryName": "Hair Growth Sevim",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241006",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241006",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "0115-1911-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01) ",
"NDC11Code": "00115-1911-01",
"ProductNDC": "0115-1911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rimantadine Hydrochloride",
"NonProprietaryName": "Rimantadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076132",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "RIMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211116",
"SamplePackage": "N",
"IndicationAndUsage": "Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).",
"Description": "Rimantadine hydrochloride, USP is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, type A and FD&C Yellow No. 6 Aluminium Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and polyethylene glycol. Rimantadine hydrochloride, USP is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride, USP is tricyclo [3.3.1.13.7]-decane-1-methanamine, α-methyl-, hydrochloride, with a molecular formula of C12H21NHCl, a molecular weight of 215.77 and the following structural formula:."
},
{
"NDCCode": "0115-1911-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02) ",
"NDC11Code": "00115-1911-02",
"ProductNDC": "0115-1911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rimantadine Hydrochloride",
"NonProprietaryName": "Rimantadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076132",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "RIMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211116",
"SamplePackage": "N",
"IndicationAndUsage": "Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).",
"Description": "Rimantadine hydrochloride, USP is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, type A and FD&C Yellow No. 6 Aluminium Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and polyethylene glycol. Rimantadine hydrochloride, USP is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride, USP is tricyclo [3.3.1.13.7]-decane-1-methanamine, α-methyl-, hydrochloride, with a molecular formula of C12H21NHCl, a molecular weight of 215.77 and the following structural formula:."
},
{
"NDCCode": "0555-9018-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9018-58",
"ProductNDC": "0555-9018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075808",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20031229",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol, USP is designated as (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol). Each active gray tablet contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (which consists of FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake), magnesium stearate, and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each active blue tablet contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white placebo tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0904-6505-06",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (0904-6505-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-6505-06",
"ProductNDC": "0904-6505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150720",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "0904-6506-06",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (0904-6506-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-6506-06",
"ProductNDC": "0904-6506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090048",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150720",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets)."
},
{
"NDCCode": "12497-1041-1",
"PackageDescription": "1 BAG in 1 DRUM (12497-1041-1) > 50 kg in 1 BAG",
"NDC11Code": "12497-1041-01",
"ProductNDC": "12497-1041",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amino Acid Mixture Kiiir",
"DosageFormName": "POWDER",
"StartMarketingDate": "19871118",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Kyowa Hakko Bio Co., Ltd.",
"SubstanceName": "SERINE; METHIONINE; LEUCINE; ISOLEUCINE; ARGININE; HISTIDINE; VALINE; THREONINE; GLYCINE; ALANINE; PROLINE",
"StrengthNumber": "3.57; 3.215; 5.5; 4.215; 5.785; 1.715; 4; 2.43; 8.5; 4.285; 6.785",
"StrengthUnit": "kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "18-NOV-87"
},
{
"NDCCode": "16590-202-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (16590-202-14)",
"NDC11Code": "16590-0202-14",
"ProductNDC": "16590-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rimantadine Hydrochloride",
"NonProprietaryName": "Rimantadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076132",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "RIMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).",
"Description": "Rimantadine hydrochloride is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate and FD&C Yellow No. 6 Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and macrogol. Rimantadine hydrochloride is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride is alpha-methyltricyclo-[3.3.1.1/3.7]decane-1-methanamine hydrochloride, with an empirical formula of C12H21NHCl, a molecular weight of 215.77 and the following structural formula:."
},
{
"NDCCode": "16590-215-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (16590-215-20)",
"NDC11Code": "16590-0215-20",
"ProductNDC": "16590-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065166",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). Cefuroxime Axetil Tablets: Cefuroxime Axetil Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. 1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefuroxime Axetil Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes. 2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes. 3. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only). (See CLINICAL STUDIES section.). NOTE: In view of the insufficient numbers of isolates of beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with Cefuroxime Axetil Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of Cefuroxime Axetil Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis. 4. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains). (See DOSAGE AND ADMINISTRATION section and CLINICAL STUDIES section.). 5. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes. 6. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae. 7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase- producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase- producing strains of Neisseria gonorrhoeae. 8. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime Axetil Tablets, USP and other antibacterial drugs, Cefuroxime Axetil Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefuroxime Axetil Tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime Axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration. Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate,72-(Z)-(O-methyl-oxime),1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime Axetil Tablets are film-coated and contain the equivalent of 125, 250, or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime Axetil Tablets contain the inactive ingredients colloidal silicon dioxide, prosolv SMCC 50, sodium lauryl sulfate, croscarmellose sodium, hydrogenated castor oil, hypromellose, propylene glycol, titanium dioxide, dewaxed shellac powder, dibutyl sebacate and polysorbate 80."
}
]
}
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<NDCCode>71334-215-50</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (71334-215-50) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-14) </PackageDescription>
<NDC11Code>71334-0215-50</NDC11Code>
<ProductNDC>71334-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MITAPIVAT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
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<NDCCode>71334-230-13</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) </PackageDescription>
<NDC11Code>71334-0230-13</NDC11Code>
<ProductNDC>71334-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>71334-205-05</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14) </PackageDescription>
<NDC11Code>71334-0205-05</NDC11Code>
<ProductNDC>71334-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MITAPIVAT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
</NDC>
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<NDCCode>71334-210-20</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (71334-210-20) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-14) </PackageDescription>
<NDC11Code>71334-0210-20</NDC11Code>
<ProductNDC>71334-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MITAPIVAT</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>71334-220-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (71334-220-11) / 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>71334-0220-11</NDC11Code>
<ProductNDC>71334-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MITAPIVAT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>71334-225-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (71334-225-12) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-07) </PackageDescription>
<NDC11Code>71334-0225-12</NDC11Code>
<ProductNDC>71334-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>16729-215-11</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (16729-215-11) </PackageDescription>
<NDC11Code>16729-0215-11</NDC11Code>
<ProductNDC>16729-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202825</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25021-215-98</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>25021-0215-98</NDC11Code>
<ProductNDC>25021-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorouracil</ProprietaryName>
<NonProprietaryName>Fluorouracil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203609</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluorouracil Injection is indicated for the treatment of patients with:.</IndicationAndUsage>
<Description>Fluorouracil Injection, USP, a nucleoside metabolic inhibitor, is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in a pharmacy bulk package, a sterile preparation that contains doses for multiple patients for intravenous administration. Each mL contains 50 mg fluorouracil in water for injection, USP. The pH is adjusted to approximately 9.2 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is:. Molecular formula: C4H3FN2O2. Molecular weight: 130.08 g/mole.</Description>
</NDC>
<NDC>
<NDCCode>42582-215-05</NDCCode>
<PackageDescription>50 TABLET, COATED in 1 BOTTLE (42582-215-05) </PackageDescription>
<NDC11Code>42582-0215-05</NDC11Code>
<ProductNDC>42582-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211343</ApplicationNumber>
<LabelerName>Bi-Coastal Pharma International, LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets, USP. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8 ∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inert ingredients for the tablet formulation are: croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose PH112, polyethylene glycol, silicon dioxide, titanium dioxide and water. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42961-215-02</NDCCode>
<PackageDescription>50 PACKAGE in 1 BOX (42961-215-02) > 5.8 mg in 1 PACKAGE</PackageDescription>
<NDC11Code>42961-0215-02</NDC11Code>
<ProductNDC>42961-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xpect Cherry Menthol Cough Drop</ProprietaryName>
<NonProprietaryName>Cherry Menthol Cough Drop</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220128</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Cintas Corp</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>5.8</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47993-215-04</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (47993-215-04)</PackageDescription>
<NDC11Code>47993-0215-04</NDC11Code>
<ProductNDC>47993-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Block Sprary</ProprietaryName>
<NonProprietaryName>Sun Block Sprary Spf15</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE</SubstanceName>
<StrengthNumber>3; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64220-215-09</NDCCode>
<PackageDescription>50 kg in 1 DRUM (64220-215-09) </PackageDescription>
<NDC11Code>64220-0215-09</NDC11Code>
<ProductNDC>64220-215</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Empagliflozin (process Ii)</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>EMPAGLIFLOZIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-04-27</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-APR-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66326-215-04</NDCCode>
<PackageDescription>50 kg in 1 DRUM (66326-215-04) </PackageDescription>
<NDC11Code>66326-0215-04</NDC11Code>
<ProductNDC>66326-215</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20200104</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Sri Krishna Pharmaceuticals Ltd. Unit 1</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>950</StrengthNumber>
<StrengthUnit>g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-JAN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67457-215-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (67457-215-01) * 10 mL in 1 VIAL, GLASS (67457-213-50) * 10 mL in 1 VIAL, GLASS (67457-214-10) </PackageDescription>
<NDC11Code>67457-0215-01</NDC11Code>
<ProductNDC>67457-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
<NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130110</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090270</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130110</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
<Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or Lsarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine. The molecular formula is C13H18Cl2N2O2 and the molecular weight is 305.20. The structural formula is. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the Lisomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of ~ 2.5. Melphalan Hydrochloride for Injection is supplied as a sterile, nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and the inactive ingredient povidone 20 mg. Melphalan Hydrochloride for Injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6.0 mL, ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan Hydrochloride for Injection is administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>68828-215-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68828-215-02) > 50 mL in 1 TUBE (68828-215-01) </PackageDescription>
<NDC11Code>68828-0215-02</NDC11Code>
<ProductNDC>68828-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oil-free Facial Sunscreen Spectrum Spf 50</ProprietaryName>
<ProprietaryNameSuffix>Jafra</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>JAFRA COSMETICS INTERNATIONAL</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10; 5; 7</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70860-215-68</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (70860-215-68) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>70860-0215-68</NDC11Code>
<ProductNDC>70860-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191130</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207326</ApplicationNumber>
<LabelerName>Athenex Pharmaceutical Division, LLC.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191130</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors (see CLINICAL STUDIES, Breast Carcinoma). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection, USP is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multi-dose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of Polyoxyl 35 Castor Oil, NF, 49.7% (v/v) Dehydrated Alcohol, USP and 2 mg Citric Acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media ‘Hicksii'. The chemical name for paclitaxel is (2a R,4 S,4a S,6 R,9 S,11 S,12 S,12a R,12b S)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4,6,9,11,12,-12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5 H-cyclodeca [3,4] benz [1,2-b] oxet-5-one 6,12b-diacetate, 12-benzoate, 9-ester with (2 R,3 S) -N-benzoyl-3-phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216° to 217°C.</Description>
</NDC>
<NDC>
<NDCCode>71919-215-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-215-09) </PackageDescription>
<NDC11Code>71919-0215-09</NDC11Code>
<ProductNDC>71919-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cochlearia Officinalis</ProprietaryName>
<NonProprietaryName>Cochlearia Officinalis Flowering Top</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>COCHLEARIA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications:. COCHLEARIA OFF Radiating stomach pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71921-215-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (71921-215-50) </PackageDescription>
<NDC11Code>71921-0215-50</NDC11Code>
<ProductNDC>71921-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202112</ApplicationNumber>
<LabelerName>Florida Pharmaceutical Products, LLC</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride tablets USP is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish- white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is. Glimepiride tablets USP contain the active ingredient glimepiride and the following inactive ingredients: lactose monohydrate, polysorbate 80, sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, Glimepiride 1 mg tablets contain Ferric Oxide Red and glimepiride 2 mg tablets contain Ferric Oxide Yellow.</Description>
</NDC>
<NDC>
<NDCCode>72415-215-50</NDCCode>
<PackageDescription>100 g in 1 TUBE (72415-215-50) </PackageDescription>
<NDC11Code>72415-0215-50</NDC11Code>
<ProductNDC>72415-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Caredo Repair Cracked Teeth Toothpastes</ProprietaryName>
<ProprietaryNameSuffix>100g</ProprietaryNameSuffix>
<NonProprietaryName>Repair Cracked Teeth Toothpaste</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20180703</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hong Kong Prosthodontics Medicine Limited</LabelerName>
<SubstanceName>GLYCINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply properly this product on the toothbrush, and brush tooth as like common do.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83872-215-01</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (83872-215-01) </PackageDescription>
<NDC11Code>83872-0215-01</NDC11Code>
<ProductNDC>83872-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Druggist Dark Spot Corrwxtor Lntimate Area</ProprietaryName>
<NonProprietaryName>Dark Spot Corrwxtor Lntimate Area</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Shenzhen Xiaomai Manufacturing Co., Ltd.</LabelerName>
<SubstanceName>4-BUTYLRESORCINOL; ARBUTIN; NIACINAMIDE</SubstanceName>
<StrengthNumber>5; 70; 30</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lighten skin spots, even skin tone, and make skin brighter.</IndicationAndUsage>
<Description>Do not use on damaged or broken skin.</Description>
</NDC>
<NDC>
<NDCCode>84347-215-50</NDCCode>
<PackageDescription>50 g in 1 BOTTLE (84347-215-50) </PackageDescription>
<NDC11Code>84347-0215-50</NDC11Code>
<ProductNDC>84347-215</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Thymosin Beta-4 Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Shenzhen Alvantis Pharma Co., Ltd.</LabelerName>
<SubstanceName>THYMOSIN .BETA.-4</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-03</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-SEP-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84522-215-01</NDCCode>
<PackageDescription>50 mL in 1 BOX (84522-215-01) </PackageDescription>
<NDC11Code>84522-0215-01</NDC11Code>
<ProductNDC>84522-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hair Growth Sevim</ProprietaryName>
<NonProprietaryName>Hair Growth Sevim</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241006</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241006</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0115-1911-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01) </PackageDescription>
<NDC11Code>00115-1911-01</NDC11Code>
<ProductNDC>0115-1911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rimantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Rimantadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076132</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>RIMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).</IndicationAndUsage>
<Description>Rimantadine hydrochloride, USP is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, type A and FD&C Yellow No. 6 Aluminium Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and polyethylene glycol. Rimantadine hydrochloride, USP is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride, USP is tricyclo [3.3.1.13.7]-decane-1-methanamine, α-methyl-, hydrochloride, with a molecular formula of C12H21NHCl, a molecular weight of 215.77 and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0115-1911-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02) </PackageDescription>
<NDC11Code>00115-1911-02</NDC11Code>
<ProductNDC>0115-1911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rimantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Rimantadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076132</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>RIMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).</IndicationAndUsage>
<Description>Rimantadine hydrochloride, USP is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, type A and FD&C Yellow No. 6 Aluminium Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and polyethylene glycol. Rimantadine hydrochloride, USP is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride, USP is tricyclo [3.3.1.13.7]-decane-1-methanamine, α-methyl-, hydrochloride, with a molecular formula of C12H21NHCl, a molecular weight of 215.77 and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0555-9018-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9018-58</NDC11Code>
<ProductNDC>0555-9018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075808</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol, USP is designated as (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol). Each active gray tablet contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (which consists of FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake), magnesium stearate, and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each active blue tablet contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white placebo tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0904-6505-06</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 CARTON (0904-6505-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6505-06</NDC11Code>
<ProductNDC>0904-6505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0904-6506-06</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 CARTON (0904-6506-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6506-06</NDC11Code>
<ProductNDC>0904-6506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090048</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a white to off-white colored powder and is slightly soluble in water. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>12497-1041-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (12497-1041-1) > 50 kg in 1 BAG</PackageDescription>
<NDC11Code>12497-1041-01</NDC11Code>
<ProductNDC>12497-1041</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amino Acid Mixture Kiiir</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19871118</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Kyowa Hakko Bio Co., Ltd.</LabelerName>
<SubstanceName>SERINE; METHIONINE; LEUCINE; ISOLEUCINE; ARGININE; HISTIDINE; VALINE; THREONINE; GLYCINE; ALANINE; PROLINE</SubstanceName>
<StrengthNumber>3.57; 3.215; 5.5; 4.215; 5.785; 1.715; 4; 2.43; 8.5; 4.285; 6.785</StrengthNumber>
<StrengthUnit>kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-NOV-87</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16590-202-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (16590-202-14)</PackageDescription>
<NDC11Code>16590-0202-14</NDC11Code>
<ProductNDC>16590-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rimantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Rimantadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076132</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>RIMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).</IndicationAndUsage>
<Description>Rimantadine hydrochloride is a synthetic antiviral drug available as a 100 mg film-coated tablet. Each film-coated tablet contains 100 mg of rimantadine hydrochloride. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate and FD&C Yellow No. 6 Lake. Film coating material, Opadry (YS-1-19025-A), contains hypromellose and macrogol. Rimantadine hydrochloride is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, rimantadine hydrochloride is alpha-methyltricyclo-[3.3.1.1/3.7]decane-1-methanamine hydrochloride, with an empirical formula of C12H21NHCl, a molecular weight of 215.77 and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>16590-215-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (16590-215-20)</PackageDescription>
<NDC11Code>16590-0215-20</NDC11Code>
<ProductNDC>16590-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065166</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). Cefuroxime Axetil Tablets: Cefuroxime Axetil Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. 1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefuroxime Axetil Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes. 2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes. 3. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only). (See CLINICAL STUDIES section.). NOTE: In view of the insufficient numbers of isolates of beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with Cefuroxime Axetil Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of Cefuroxime Axetil Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis. 4. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains). (See DOSAGE AND ADMINISTRATION section and CLINICAL STUDIES section.). 5. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes. 6. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae. 7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase- producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase- producing strains of Neisseria gonorrhoeae. 8. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime Axetil Tablets, USP and other antibacterial drugs, Cefuroxime Axetil Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefuroxime Axetil Tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime Axetil is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration. Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate,72-(Z)-(O-methyl-oxime),1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime Axetil Tablets are film-coated and contain the equivalent of 125, 250, or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime Axetil Tablets contain the inactive ingredients colloidal silicon dioxide, prosolv SMCC 50, sodium lauryl sulfate, croscarmellose sodium, hydrogenated castor oil, hypromellose, propylene glycol, titanium dioxide, dewaxed shellac powder, dibutyl sebacate and polysorbate 80.</Description>
</NDC>
</NDCList>