{
"NDC": [
{
"NDCCode": "0054-0339-19",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (0054-0339-19) ",
"NDC11Code": "00054-0339-19",
"ProductNDC": "0054-0339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxercalciferol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091433",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": "2.5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS],Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140218",
"SamplePackage": "N",
"IndicationAndUsage": "Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.",
"Description": "Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a white to off-white powder with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in N,N-dimethylformamide, sparingly soluble in methanol, slightly soluble in acetonitrile and practically insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-Seco-ergosta-5,7,10(19),22-tetraene-1,3-diol and has the following structural formula. Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2 and 1α-hydroxyergocalciferol. Doxercalciferol Capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "36800-339-19",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-339-19) > 120 mL in 1 BOTTLE",
"NDC11Code": "36800-0339-19",
"ProductNDC": "36800-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illuminating Daily Moisturizer",
"NonProprietaryName": "Avobenzone, Octisalate And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120511",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 5; 8",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "43353-339-19",
"PackageDescription": "3060 TABLET in 1 BOTTLE (43353-339-19)",
"NDC11Code": "43353-0339-19",
"ProductNDC": "43353-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079170",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "49349-339-19",
"PackageDescription": "90 TABLET in 1 BOTTLE (49349-339-19)",
"NDC11Code": "49349-0339-19",
"ProductNDC": "49349-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078010",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0054-0338-19",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (0054-0338-19) ",
"NDC11Code": "00054-0338-19",
"ProductNDC": "0054-0338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxercalciferol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091433",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": ".5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS],Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140218",
"SamplePackage": "N",
"IndicationAndUsage": "Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.",
"Description": "Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a white to off-white powder with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in N,N-dimethylformamide, sparingly soluble in methanol, slightly soluble in acetonitrile and practically insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-Seco-ergosta-5,7,10(19),22-tetraene-1,3-diol and has the following structural formula. Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2 and 1α-hydroxyergocalciferol. Doxercalciferol Capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "0054-0388-19",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (0054-0388-19) ",
"NDC11Code": "00054-0388-19",
"ProductNDC": "0054-0388",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxercalciferol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091433",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": "1",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS],Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140218",
"SamplePackage": "N",
"IndicationAndUsage": "Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.",
"Description": "Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a white to off-white powder with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in N,N-dimethylformamide, sparingly soluble in methanol, slightly soluble in acetonitrile and practically insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-Seco-ergosta-5,7,10(19),22-tetraene-1,3-diol and has the following structural formula. Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2 and 1α-hydroxyergocalciferol. Doxercalciferol Capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "0054-0702-19",
"PackageDescription": "50 PACKET in 1 CARTON (0054-0702-19) / 10 mL in 1 PACKET",
"NDC11Code": "00054-0702-19",
"ProductNDC": "0054-0702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vigabatrin For Oral Solution Usp, 500 Mg",
"NonProprietaryName": "Vigabatrin",
"DosageFormName": "FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213469",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VIGABATRIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200710",
"SamplePackage": "N",
"IndicationAndUsage": "Vigabatrin for oral solution is indicated for the treatment of: 1 Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin for oral solution is not indicated as a first line agent ( 1.1) , 2 Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2) .",
"Description": "Vigabatrin, USP is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin, USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6H 11NO 2 and the molecular weight is 129.16. It has the following structural formula:. Vigabatrin, USP is a white to off white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96 at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25°C). Vigabatrin for oral solution USP, is available as white to off-white granular powder for oral administration. Each packet contains 500 mg of vigabatrin, USP. The inactive ingredient is povidone."
},
{
"NDCCode": "0054-0711-19",
"PackageDescription": "50 TABLET, COATED in 1 BOTTLE (0054-0711-19) ",
"NDC11Code": "00054-0711-19",
"ProductNDC": "0054-0711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferiprone",
"NonProprietaryName": "Deferiprone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213239",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERIPRONE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use: 1 Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.",
"Description": "Deferiprone tablets contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white crystalline powder. It is slightly soluble in deionized water and has a melting point range of 271°C - 273°C. Deferiprone Tablets (three times a day), 1,000 mg. Deferiprone tablets, 1,000 mg are white to off-white, modified capsule shaped, biconvex, film coated tablet, debossed with 54 [score] 23 on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core: methylcellulose, crospovidone, magnesium stearate; Coating: hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "0054-8496-19",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0054-8496-19) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-8496-19",
"ProductNDC": "0054-8496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "23155-054-19",
"PackageDescription": "9 TABLET in 1 BLISTER PACK (23155-054-19) ",
"NDC11Code": "23155-0054-19",
"ProductNDC": "23155-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110315",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "42291-339-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42291-339-30) ",
"NDC11Code": "42291-0339-30",
"ProductNDC": "42291-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130124",
"SamplePackage": "N"
},
{
"NDCCode": "42291-339-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42291-339-60) ",
"NDC11Code": "42291-0339-60",
"ProductNDC": "42291-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150505",
"SamplePackage": "N"
},
{
"NDCCode": "42291-339-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-339-90) ",
"NDC11Code": "42291-0339-90",
"ProductNDC": "42291-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130124",
"SamplePackage": "N"
},
{
"NDCCode": "42508-339-11",
"PackageDescription": "3 g in 1 TUBE (42508-339-11) ",
"NDC11Code": "42508-0339-11",
"ProductNDC": "42508-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arbonne Re9 Advanced",
"ProprietaryNameSuffix": "Extra Moisture Restorative Day Spf 20",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170417",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 75; 50; 27.9",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170417",
"EndMarketingDatePackage": "20190918",
"SamplePackage": "N"
},
{
"NDCCode": "42508-339-15",
"PackageDescription": "15 g in 1 TUBE (42508-339-15) ",
"NDC11Code": "42508-0339-15",
"ProductNDC": "42508-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arbonne Re9 Advanced",
"ProprietaryNameSuffix": "Extra Moisture Restorative Day Spf 20",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170417",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 75; 50; 27.9",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170417",
"EndMarketingDatePackage": "20190918",
"SamplePackage": "N"
},
{
"NDCCode": "50742-339-30",
"PackageDescription": "6 POUCH in 1 CARTON (50742-339-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-339-05) / .3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50742-0339-30",
"ProductNDC": "50742-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tafluprost",
"NonProprietaryName": "Tafluprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20241218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218002",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "TAFLUPROST",
"StrengthNumber": ".015",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241218",
"SamplePackage": "N",
"IndicationAndUsage": "Tafluprost ophthalmic solution, 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.",
"Description": "Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is Propan-2-yl (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3 difluoro-4-phenoxybut-1-enyl]-3,5-dihydroxycyclopentyl}hept-5-enoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.5. Its structural formula is. Tafluprost is a colorless to yellowish hygroscopic oil that is very soluble in acetone, acetonitrile, dichloromethane, diethylether, ethanol, methanol and tert-butyl(methyl)ether and practically insoluble in n-heptane and water. Tafluprost ophthalmic solution, 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmol/kg. Tafluprost ophthalmic solution contains Active: tafluprost 0.015 mg/mL; Inactives: glycerin, monobasic sodium phosphate dihydrate, edetate disodium dihydrate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. Tafluprost ophthalmic solution does not contain a preservative."
},
{
"NDCCode": "67457-339-50",
"PackageDescription": "10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00) ",
"NDC11Code": "67457-0339-50",
"ProductNDC": "67457-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065397",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula."
},
{
"NDCCode": "67651-0339-0",
"PackageDescription": "18200 TABLET in 1 DRUM (67651-0339-0) ",
"NDC11Code": "67651-0339-00",
"ProductNDC": "67651-0339",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Benzhydrocodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"StartMarketingDate": "20190628",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Pharmaceuticals Inc.",
"SubstanceName": "ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 8.16",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "28-JUN-19",
"EndMarketingDatePackage": "31-OCT-25"
},
{
"NDCCode": "69367-339-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (69367-339-01) ",
"NDC11Code": "69367-0339-01",
"ProductNDC": "69367-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214092",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/ 100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/ 100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/ 250 mg also contain FD&C Blue #2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow #10."
},
{
"NDCCode": "69367-339-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (69367-339-05) ",
"NDC11Code": "69367-0339-05",
"ProductNDC": "69367-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214092",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/ 100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/ 100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/ 250 mg also contain FD&C Blue #2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow #10."
},
{
"NDCCode": "69367-339-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (69367-339-10) ",
"NDC11Code": "69367-0339-10",
"ProductNDC": "69367-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214092",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210930",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
"Description": "Carbidopa and levodopa tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/ 100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/ 100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/ 250 mg also contain FD&C Blue #2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow #10."
},
{
"NDCCode": "69423-339-73",
"PackageDescription": "73 g in 1 CANISTER (69423-339-73) ",
"NDC11Code": "69423-0339-73",
"ProductNDC": "69423-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Fresh And Free Invisible",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190108",
"EndMarketingDate": "20210110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190108",
"EndMarketingDatePackage": "20210110",
"SamplePackage": "N"
},
{
"NDCCode": "70281-339-03",
"PackageDescription": "4.25 g in 1 CONTAINER (70281-339-03)",
"NDC11Code": "70281-0339-03",
"ProductNDC": "70281-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bullfrog Land Sport Spf 50 Lip Balm",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene And Oxybenzone",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SolSkyn Personal Care LLC",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 4; 10; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": " helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "70748-339-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (70748-339-01) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "70748-0339-01",
"ProductNDC": "70748-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxorubicin Hydrochloride",
"NonProprietaryName": "Doxorubicin Hydrochloride",
"DosageFormName": "INJECTION, SUSPENSION, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215178",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DOXORUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240826",
"SamplePackage": "N",
"IndicationAndUsage": "Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer:After failure of platinum-based chemotherapy (1.1), 2 AIDS-related Kaposi's Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy (1.2)., 3 Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).",
"Description": "The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl and the molecular weight is 579.99. The structural formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes. MPEG-DSPE has the following structural formula. HSPC has the following structural formula. Representation of a pegylated liposome."
},
{
"NDCCode": "74052-339-01",
"PackageDescription": "3785.41 mL in 1 BOTTLE, PUMP (74052-339-01) ",
"NDC11Code": "74052-0339-01",
"ProductNDC": "74052-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hygenize Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"EndMarketingDate": "20200920",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Iris LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200403",
"EndMarketingDatePackage": "20200920",
"SamplePackage": "N"
},
{
"NDCCode": "84515-339-01",
"PackageDescription": "30 g in 1 BOX (84515-339-01) ",
"NDC11Code": "84515-0339-01",
"ProductNDC": "84515-339",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Dark Spot Corrector Cream",
"NonProprietaryName": "Trstay Dark Spot Corrector Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241014",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241014",
"EndMarketingDatePackage": "20311031",
"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": "0054-0007-13",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13) ",
"NDC11Code": "00054-0007-13",
"ProductNDC": "0054-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076917",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060327",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available containing 0.25 mcg of calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA 35A alcohol. Calcitriol, USP is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol, USP is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: 1 , 2 C27H44O3."
},
{
"NDCCode": "0054-0007-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25) ",
"NDC11Code": "00054-0007-25",
"ProductNDC": "0054-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076917",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060327",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available containing 0.25 mcg of calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA 35A alcohol. Calcitriol, USP is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol, USP is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: 1 , 2 C27H44O3."
},
{
"NDCCode": "0054-0057-46",
"PackageDescription": "60 mL in 1 BOTTLE (0054-0057-46) ",
"NDC11Code": "00054-0057-46",
"ProductNDC": "0054-0057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20040826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021648",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040826",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. (1.1, 1.3) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. (1.2).",
"Description": "Digoxin is one of the cardiac glycosides, a closely-related group of plant-derived drugs with shared pharmacological effects. The term \"digitalis\" is used to designate the whole group. Digoxin is extracted from the leaves of the common foxglove, Digitalis lanata. Like each of the other cardiac glycosides, digoxin consists of a polycyclic core and a sugar side chain. Digoxin’s chemical name is 3β-[O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide; its structural formula is. Its molecular formula is C41H64O14, and its molecular weight is 780.94. Digoxin is practically insoluble in water and in ether, slightly soluble in 50% ethanol and in chloroform, and freely soluble in pyridine. Digoxin, USP is a white or almost white powder, or colorless crystals. Digoxin Oral Solution, USP is formulated for oral administration. Each mL contains 50 mcg digoxin. The lime-flavored solution contains the following inactive ingredients: alcohol 10% (by volume at 60°F), glycerin, lime (imitation), methylparaben 0.1%, propylparaben 0.02%, purified water, sodium citrate and sorbitol solution."
},
{
"NDCCode": "0054-0064-47",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00054-0064-47",
"ProductNDC": "0054-0064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20061226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076960",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061226",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron is indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron oral solution, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-carbazol-4-one, 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-, monohydrochloride, (±)-, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride, USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Each 5 mL of ondansetron oral solution, USP contains 5 mg of ondansetron hydrochloride, USP (dihydrate) equivalent to 4 mg of ondansetron (base) and the following inactive ingredients: anhydrous citric acid, glycerin, purified water, saccharin sodium, sodium citrate, sodium benzoate and strawberry flavor."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0054-0339-19</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (0054-0339-19) </PackageDescription>
<NDC11Code>00054-0339-19</NDC11Code>
<ProductNDC>0054-0339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxercalciferol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091433</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS],Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.</IndicationAndUsage>
<Description>Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a white to off-white powder with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in N,N-dimethylformamide, sparingly soluble in methanol, slightly soluble in acetonitrile and practically insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-Seco-ergosta-5,7,10(19),22-tetraene-1,3-diol and has the following structural formula. Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2 and 1α-hydroxyergocalciferol. Doxercalciferol Capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>36800-339-19</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-339-19) > 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0339-19</NDC11Code>
<ProductNDC>36800-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illuminating Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 5; 8</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43353-339-19</NDCCode>
<PackageDescription>3060 TABLET in 1 BOTTLE (43353-339-19)</PackageDescription>
<NDC11Code>43353-0339-19</NDC11Code>
<ProductNDC>43353-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079170</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration.The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5 yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white to offwhite powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.Rosuvastatin calcium tablets for oral administration contain 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>49349-339-19</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (49349-339-19)</PackageDescription>
<NDC11Code>49349-0339-19</NDC11Code>
<ProductNDC>49349-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078010</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0054-0338-19</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (0054-0338-19) </PackageDescription>
<NDC11Code>00054-0338-19</NDC11Code>
<ProductNDC>0054-0338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxercalciferol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091433</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS],Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.</IndicationAndUsage>
<Description>Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a white to off-white powder with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in N,N-dimethylformamide, sparingly soluble in methanol, slightly soluble in acetonitrile and practically insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-Seco-ergosta-5,7,10(19),22-tetraene-1,3-diol and has the following structural formula. Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2 and 1α-hydroxyergocalciferol. Doxercalciferol Capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0054-0388-19</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (0054-0388-19) </PackageDescription>
<NDC11Code>00054-0388-19</NDC11Code>
<ProductNDC>0054-0388</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxercalciferol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091433</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS],Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.</IndicationAndUsage>
<Description>Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Doxercalciferol is a white to off-white powder with a calculated molecular weight of 412.65 and a molecular formula of C28H44O2. It is soluble in N,N-dimethylformamide, sparingly soluble in methanol, slightly soluble in acetonitrile and practically insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-Seco-ergosta-5,7,10(19),22-tetraene-1,3-diol and has the following structural formula. Other names frequently used for doxercalciferol are 1α-hydroxyvitamin D2 and 1α-hydroxyergocalciferol. Doxercalciferol Capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain triglyceride. The capsule shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow No. 6 (1 mcg only), FD&C Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified water, and titanium dioxide. Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0054-0702-19</NDCCode>
<PackageDescription>50 PACKET in 1 CARTON (0054-0702-19) / 10 mL in 1 PACKET</PackageDescription>
<NDC11Code>00054-0702-19</NDC11Code>
<ProductNDC>0054-0702</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vigabatrin For Oral Solution Usp, 500 Mg</ProprietaryName>
<NonProprietaryName>Vigabatrin</NonProprietaryName>
<DosageFormName>FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213469</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VIGABATRIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vigabatrin for oral solution is indicated for the treatment of: 1 Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin for oral solution is not indicated as a first line agent ( 1.1) , 2 Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2) .</IndicationAndUsage>
<Description>Vigabatrin, USP is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin, USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6H 11NO 2 and the molecular weight is 129.16. It has the following structural formula:. Vigabatrin, USP is a white to off white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96 at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25°C). Vigabatrin for oral solution USP, is available as white to off-white granular powder for oral administration. Each packet contains 500 mg of vigabatrin, USP. The inactive ingredient is povidone.</Description>
</NDC>
<NDC>
<NDCCode>0054-0711-19</NDCCode>
<PackageDescription>50 TABLET, COATED in 1 BOTTLE (0054-0711-19) </PackageDescription>
<NDC11Code>00054-0711-19</NDC11Code>
<ProductNDC>0054-0711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferiprone</ProprietaryName>
<NonProprietaryName>Deferiprone</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213239</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERIPRONE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use: 1 Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.</IndicationAndUsage>
<Description>Deferiprone tablets contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white crystalline powder. It is slightly soluble in deionized water and has a melting point range of 271°C - 273°C. Deferiprone Tablets (three times a day), 1,000 mg. Deferiprone tablets, 1,000 mg are white to off-white, modified capsule shaped, biconvex, film coated tablet, debossed with 54 [score] 23 on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core: methylcellulose, crospovidone, magnesium stearate; Coating: hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0054-8496-19</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0054-8496-19) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-8496-19</NDC11Code>
<ProductNDC>0054-8496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072733</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>23155-054-19</NDCCode>
<PackageDescription>9 TABLET in 1 BLISTER PACK (23155-054-19) </PackageDescription>
<NDC11Code>23155-0054-19</NDC11Code>
<ProductNDC>23155-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-339-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42291-339-30) </PackageDescription>
<NDC11Code>42291-0339-30</NDC11Code>
<ProductNDC>42291-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-339-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42291-339-60) </PackageDescription>
<NDC11Code>42291-0339-60</NDC11Code>
<ProductNDC>42291-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-339-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-339-90) </PackageDescription>
<NDC11Code>42291-0339-90</NDC11Code>
<ProductNDC>42291-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42508-339-11</NDCCode>
<PackageDescription>3 g in 1 TUBE (42508-339-11) </PackageDescription>
<NDC11Code>42508-0339-11</NDC11Code>
<ProductNDC>42508-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arbonne Re9 Advanced</ProprietaryName>
<ProprietaryNameSuffix>Extra Moisture Restorative Day Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Arbonne International, LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 75; 50; 27.9</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170417</StartMarketingDatePackage>
<EndMarketingDatePackage>20190918</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42508-339-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (42508-339-15) </PackageDescription>
<NDC11Code>42508-0339-15</NDC11Code>
<ProductNDC>42508-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arbonne Re9 Advanced</ProprietaryName>
<ProprietaryNameSuffix>Extra Moisture Restorative Day Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Arbonne International, LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 75; 50; 27.9</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170417</StartMarketingDatePackage>
<EndMarketingDatePackage>20190918</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50742-339-30</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (50742-339-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-339-05) / .3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50742-0339-30</NDC11Code>
<ProductNDC>50742-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tafluprost</ProprietaryName>
<NonProprietaryName>Tafluprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20241218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218002</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TAFLUPROST</SubstanceName>
<StrengthNumber>.015</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tafluprost ophthalmic solution, 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is Propan-2-yl (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3 difluoro-4-phenoxybut-1-enyl]-3,5-dihydroxycyclopentyl}hept-5-enoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.5. Its structural formula is. Tafluprost is a colorless to yellowish hygroscopic oil that is very soluble in acetone, acetonitrile, dichloromethane, diethylether, ethanol, methanol and tert-butyl(methyl)ether and practically insoluble in n-heptane and water. Tafluprost ophthalmic solution, 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmol/kg. Tafluprost ophthalmic solution contains Active: tafluprost 0.015 mg/mL; Inactives: glycerin, monobasic sodium phosphate dihydrate, edetate disodium dihydrate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. Tafluprost ophthalmic solution does not contain a preservative.</Description>
</NDC>
<NDC>
<NDCCode>67457-339-50</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-339-50) / 10 mL in 1 VIAL (67457-339-00) </PackageDescription>
<NDC11Code>67457-0339-50</NDC11Code>
<ProductNDC>67457-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065397</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>67651-0339-0</NDCCode>
<PackageDescription>18200 TABLET in 1 DRUM (67651-0339-0) </PackageDescription>
<NDC11Code>67651-0339-00</NDC11Code>
<ProductNDC>67651-0339</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Benzhydrocodone Hydrochloride And Acetaminophen</NonProprietaryName>
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<StartMarketingDate>20190628</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 8.16</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>28-JUN-19</StartMarketingDatePackage>
<EndMarketingDatePackage>31-OCT-25</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69367-339-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (69367-339-01) </PackageDescription>
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<ProductNDC>69367-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214092</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/ 100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/ 100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/ 250 mg also contain FD&C Blue #2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>69367-339-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (69367-339-05) </PackageDescription>
<NDC11Code>69367-0339-05</NDC11Code>
<ProductNDC>69367-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214092</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/ 100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/ 100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/ 250 mg also contain FD&C Blue #2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>69367-339-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (69367-339-10) </PackageDescription>
<NDC11Code>69367-0339-10</NDC11Code>
<ProductNDC>69367-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214092</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
<Description>Carbidopa and levodopa tablet, USP is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4, and its structural formula is. Carbidopa and levodopa is supplied as tablets in three strengths. Carbidopa and levodopa tablets, USP 10 mg/ 100 mg, containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/ 100 mg, containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets, USP 25 mg/250 mg, containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets, USP 10 mg/100 mg and 25 mg/ 250 mg also contain FD&C Blue #2. Carbidopa and levodopa tablets, USP 25 mg/100 mg also contain D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>69423-339-73</NDCCode>
<PackageDescription>73 g in 1 CANISTER (69423-339-73) </PackageDescription>
<NDC11Code>69423-0339-73</NDC11Code>
<ProductNDC>69423-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Fresh And Free Invisible</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190108</StartMarketingDate>
<EndMarketingDate>20210110</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190108</StartMarketingDatePackage>
<EndMarketingDatePackage>20210110</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70281-339-03</NDCCode>
<PackageDescription>4.25 g in 1 CONTAINER (70281-339-03)</PackageDescription>
<NDC11Code>70281-0339-03</NDC11Code>
<ProductNDC>70281-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bullfrog Land Sport Spf 50 Lip Balm</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene And Oxybenzone</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SolSkyn Personal Care LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2; 4; 10; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage> helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70748-339-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (70748-339-01) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>70748-0339-01</NDC11Code>
<ProductNDC>70748-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxorubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxorubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, LIPOSOMAL</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215178</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXORUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: 1 Ovarian cancer:After failure of platinum-based chemotherapy (1.1), 2 AIDS-related Kaposi's Sarcoma:After failure of prior systemic chemotherapy or intolerance to such therapy (1.2)., 3 Multiple Myeloma:In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).</IndicationAndUsage>
<Description>The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27H29NO11HCl and the molecular weight is 579.99. The structural formula is. Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes. MPEG-DSPE has the following structural formula. HSPC has the following structural formula. Representation of a pegylated liposome.</Description>
</NDC>
<NDC>
<NDCCode>74052-339-01</NDCCode>
<PackageDescription>3785.41 mL in 1 BOTTLE, PUMP (74052-339-01) </PackageDescription>
<NDC11Code>74052-0339-01</NDC11Code>
<ProductNDC>74052-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hygenize Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<EndMarketingDate>20200920</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Iris LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200403</StartMarketingDatePackage>
<EndMarketingDatePackage>20200920</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84515-339-01</NDCCode>
<PackageDescription>30 g in 1 BOX (84515-339-01) </PackageDescription>
<NDC11Code>84515-0339-01</NDC11Code>
<ProductNDC>84515-339</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName>
<NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241014</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241014</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</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>0054-0007-13</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13) </PackageDescription>
<NDC11Code>00054-0007-13</NDC11Code>
<ProductNDC>0054-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076917</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available containing 0.25 mcg of calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA 35A alcohol. Calcitriol, USP is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol, USP is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: 1 , 2 C27H44O3.</Description>
</NDC>
<NDC>
<NDCCode>0054-0007-25</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25) </PackageDescription>
<NDC11Code>00054-0007-25</NDC11Code>
<ProductNDC>0054-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076917</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available containing 0.25 mcg of calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA 35A alcohol. Calcitriol, USP is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol, USP is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: 1 , 2 C27H44O3.</Description>
</NDC>
<NDC>
<NDCCode>0054-0057-46</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (0054-0057-46) </PackageDescription>
<NDC11Code>00054-0057-46</NDC11Code>
<ProductNDC>0054-0057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021648</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. (1.1, 1.3) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. (1.2).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac glycosides, a closely-related group of plant-derived drugs with shared pharmacological effects. The term "digitalis" is used to designate the whole group. Digoxin is extracted from the leaves of the common foxglove, Digitalis lanata. Like each of the other cardiac glycosides, digoxin consists of a polycyclic core and a sugar side chain. Digoxin’s chemical name is 3β-[O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide; its structural formula is. Its molecular formula is C41H64O14, and its molecular weight is 780.94. Digoxin is practically insoluble in water and in ether, slightly soluble in 50% ethanol and in chloroform, and freely soluble in pyridine. Digoxin, USP is a white or almost white powder, or colorless crystals. Digoxin Oral Solution, USP is formulated for oral administration. Each mL contains 50 mcg digoxin. The lime-flavored solution contains the following inactive ingredients: alcohol 10% (by volume at 60°F), glycerin, lime (imitation), methylparaben 0.1%, propylparaben 0.02%, purified water, sodium citrate and sorbitol solution.</Description>
</NDC>
<NDC>
<NDCCode>0054-0064-47</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00054-0064-47</NDC11Code>
<ProductNDC>0054-0064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076960</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron is indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2., 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron oral solution, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-carbazol-4-one, 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-, monohydrochloride, (±)-, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride, USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Each 5 mL of ondansetron oral solution, USP contains 5 mg of ondansetron hydrochloride, USP (dihydrate) equivalent to 4 mg of ondansetron (base) and the following inactive ingredients: anhydrous citric acid, glycerin, purified water, saccharin sodium, sodium citrate, sodium benzoate and strawberry flavor.</Description>
</NDC>
</NDCList>