{
"NDC": [
{
"NDCCode": "63739-653-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-653-10) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "63739-0653-10",
"ProductNDC": "63739-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090175",
"LabelerName": "McKesson Packaging Services a business unit of McKesson Corporation",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "14539-653-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (14539-653-10) ",
"NDC11Code": "14539-0653-10",
"ProductNDC": "14539-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211682",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190601",
"SamplePackage": "N"
},
{
"NDCCode": "31722-653-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (31722-653-10) ",
"NDC11Code": "31722-0653-10",
"ProductNDC": "31722-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atazanavir",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212278",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220207",
"SamplePackage": "N",
"IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4)] . Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4)] .",
"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is ((3 S,8 S,9 S,12 S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl] 2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate. Its molecular formula is C 38H 52N 6O 7.H 2SO 4which corresponds to a molecular weight of 802.9 (sulphuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:. Atazanavir sulfate is an off white to pale yellow coloured crystalline powder. It is slightly soluble in water at acidic pH, freely soluble in methanol, soluble in dimethylformamide and dimethylsulfoxide. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue 1, iron oxide yellow, titanium dioxide, In addition 150 mg capsule shell contains iron oxide black, 200 mg and 300 mg contains FD&C Yellow 6, 300 mg also contains FD&C Red 3. The capsules are printed with black ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "31722-653-31",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (31722-653-31) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0653-31",
"ProductNDC": "31722-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atazanavir",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212278",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220207",
"SamplePackage": "N",
"IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4)] . Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4)] .",
"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is ((3 S,8 S,9 S,12 S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl] 2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate. Its molecular formula is C 38H 52N 6O 7.H 2SO 4which corresponds to a molecular weight of 802.9 (sulphuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:. Atazanavir sulfate is an off white to pale yellow coloured crystalline powder. It is slightly soluble in water at acidic pH, freely soluble in methanol, soluble in dimethylformamide and dimethylsulfoxide. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue 1, iron oxide yellow, titanium dioxide, In addition 150 mg capsule shell contains iron oxide black, 200 mg and 300 mg contains FD&C Yellow 6, 300 mg also contains FD&C Red 3. The capsules are printed with black ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "40032-653-10",
"PackageDescription": "1000 TABLET, CHEWABLE in 1 BOTTLE (40032-653-10) ",
"NDC11Code": "40032-0653-10",
"ProductNDC": "40032-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206793",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160308",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "40032-653-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (40032-653-30) > 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "40032-0653-30",
"ProductNDC": "40032-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206793",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160308",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "43063-653-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (43063-653-10) ",
"NDC11Code": "43063-0653-10",
"ProductNDC": "43063-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201278",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160125",
"SamplePackage": "N"
},
{
"NDCCode": "52959-653-10",
"PackageDescription": "10 CAPSULE, COATED in 1 BOTTLE, PLASTIC (52959-653-10)",
"NDC11Code": "52959-0653-10",
"ProductNDC": "52959-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065028",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC],Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin capsules, USP contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze, propylene glycol, simethicone, and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piper-azinyl)formimidoyl]-2,7-(epoxypentadeca-[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "57664-653-10",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (57664-653-10)",
"NDC11Code": "57664-0653-10",
"ProductNDC": "57664-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19860716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070772",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "65862-653-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65862-653-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10) ",
"NDC11Code": "65862-0653-03",
"ProductNDC": "65862-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203175",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white, colored powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as modified caplet shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, hydroxy propyl cellulose, microcrystalline cellulose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide."
},
{
"NDCCode": "65862-653-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-653-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10) ",
"NDC11Code": "65862-0653-78",
"ProductNDC": "65862-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203175",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white, colored powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as modified caplet shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, hydroxy propyl cellulose, microcrystalline cellulose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide."
},
{
"NDCCode": "66267-653-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (66267-653-10) ",
"NDC11Code": "66267-0653-10",
"ProductNDC": "66267-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"ProprietaryNameSuffix": "Antihistamine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170719",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat ."
},
{
"NDCCode": "68001-653-17",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68001-653-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-653-16) ",
"NDC11Code": "68001-0653-17",
"ProductNDC": "68001-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenatane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251224",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "68382-653-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68382-653-10) ",
"NDC11Code": "68382-0653-10",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "68382-653-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30) ",
"NDC11Code": "68382-0653-77",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "70860-653-10",
"PackageDescription": "25 VIAL in 1 CARTON (70860-653-10) > 10 mL in 1 VIAL (70860-653-41) ",
"NDC11Code": "70860-0653-10",
"ProductNDC": "70860-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211504",
"LabelerName": "Athenex Pharmaceutical Division, LLC.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N"
},
{
"NDCCode": "71205-653-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-10) ",
"NDC11Code": "71205-0653-10",
"ProductNDC": "71205-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062676",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2022-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220412",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "71919-653-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-653-10) ",
"NDC11Code": "71919-0653-10",
"ProductNDC": "71919-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulfur",
"NonProprietaryName": "Sulfur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SULFUR",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "72485-653-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "72485-0653-10",
"ProductNDC": "72485-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20231024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215933",
"LabelerName": "ARMAS PHARMACEUTICALS INC.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231024",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.",
"Description": "Loteprednol Etabonate Ophthalmic Suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Water for Injection and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%."
},
{
"NDCCode": "75936-653-02",
"PackageDescription": "10 mL in 1 TUBE (75936-653-02) ",
"NDC11Code": "75936-0653-02",
"ProductNDC": "75936-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Play Everyday Face Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Supergoop, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 7.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "63739-003-33",
"PackageDescription": "3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63739-0003-33",
"ProductNDC": "63739-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120628",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151104",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules, USP 7.5 mg, are for oral administration. 7.5 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "63739-004-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-004-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0004-10",
"ProductNDC": "63739-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19880930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089805",
"LabelerName": "McKesson Corporation",
"SubstanceName": "CODEINE PHOSPHATE; ACETAMINOPHEN",
"StrengthNumber": "30; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19880930",
"SamplePackage": "N"
},
{
"NDCCode": "63739-005-32",
"PackageDescription": "4 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-005-32) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63739-0005-32",
"ProductNDC": "63739-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120302",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077565",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160111",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia. Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)] Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].",
"Description": "Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone capsules, USP contain a hydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride USP is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, hydrochloride. The molecular formula is C 21H 21ClN 4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride USP is a light pink to pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride, USP, anhydrous lactose, magnesium stearate, polysorbate 80, povidone (PVK-30), pregelatinized starch and silicon dioxide. The components of the capsule shells are FD&C Blue #1, FD&C Red #3, gelatin, red iron oxide and titanium dioxide. The capsule shells are imprinted with black ink. The components of black ink (Black SW-9008/SW-9009) are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Ziprasidone capsules meets USP Dissolution Test 3."
},
{
"NDCCode": "63739-006-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-006-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0006-10",
"ProductNDC": "63739-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090635",
"LabelerName": "McKesson Corporation",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160105",
"SamplePackage": "N"
},
{
"NDCCode": "63739-007-10",
"PackageDescription": "10 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (63739-007-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0007-10",
"ProductNDC": "63739-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078220",
"LabelerName": "McKesson Corporation",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N"
},
{
"NDCCode": "63739-008-33",
"PackageDescription": "3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-008-33) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0008-33",
"ProductNDC": "63739-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160531",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206181",
"LabelerName": "Mckesson Corporation DBA SKY Packaginng",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160531",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis (1.1) Candidemia in non-neutropenics and other deep tissue Candida infections (1.2) Esophageal candidiasis (1.3) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).",
"Description": "Voriconazole USP, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR,βS)-α-(2,4-difluorophenyl)-5- fluoro- β -methyl- α -(1H-1,2,4-traizol-l-ylmethyl)-4-pyrimidineethanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.31 g/mole. Voriconazole drug substance is a white or almost white powder. Voriconazole tablets contain 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin."
},
{
"NDCCode": "63739-013-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-013-10) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0013-10",
"ProductNDC": "63739-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074260",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170628",
"SamplePackage": "N"
},
{
"NDCCode": "63739-014-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-014-10) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "63739-0014-10",
"ProductNDC": "63739-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170713",
"EndMarketingDatePackage": "20210831",
"SamplePackage": "N"
},
{
"NDCCode": "63739-015-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-015-10) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "63739-0015-10",
"ProductNDC": "63739-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170713",
"EndMarketingDatePackage": "20210831",
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},
{
"NDCCode": "63739-016-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-016-10) / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "63739-0016-10",
"ProductNDC": "63739-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170713",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
}
]
}
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<NDCList>
<NDC>
<NDCCode>63739-653-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-653-10) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0653-10</NDC11Code>
<ProductNDC>63739-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090175</ApplicationNumber>
<LabelerName>McKesson Packaging Services a business unit of McKesson Corporation</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>14539-653-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (14539-653-10) </PackageDescription>
<NDC11Code>14539-0653-10</NDC11Code>
<ProductNDC>14539-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211682</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-653-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (31722-653-10) </PackageDescription>
<NDC11Code>31722-0653-10</NDC11Code>
<ProductNDC>31722-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atazanavir</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212278</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4)] . Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4)] .</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is ((3 S,8 S,9 S,12 S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl] 2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate. Its molecular formula is C 38H 52N 6O 7.H 2SO 4which corresponds to a molecular weight of 802.9 (sulphuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:. Atazanavir sulfate is an off white to pale yellow coloured crystalline powder. It is slightly soluble in water at acidic pH, freely soluble in methanol, soluble in dimethylformamide and dimethylsulfoxide. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue 1, iron oxide yellow, titanium dioxide, In addition 150 mg capsule shell contains iron oxide black, 200 mg and 300 mg contains FD&C Yellow 6, 300 mg also contains FD&C Red 3. The capsules are printed with black ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-653-31</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (31722-653-31) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0653-31</NDC11Code>
<ProductNDC>31722-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atazanavir</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212278</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4)] . Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4)] .</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is ((3 S,8 S,9 S,12 S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl] 2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate. Its molecular formula is C 38H 52N 6O 7.H 2SO 4which corresponds to a molecular weight of 802.9 (sulphuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:. Atazanavir sulfate is an off white to pale yellow coloured crystalline powder. It is slightly soluble in water at acidic pH, freely soluble in methanol, soluble in dimethylformamide and dimethylsulfoxide. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue 1, iron oxide yellow, titanium dioxide, In addition 150 mg capsule shell contains iron oxide black, 200 mg and 300 mg contains FD&C Yellow 6, 300 mg also contains FD&C Red 3. The capsules are printed with black ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>40032-653-10</NDCCode>
<PackageDescription>1000 TABLET, CHEWABLE in 1 BOTTLE (40032-653-10) </PackageDescription>
<NDC11Code>40032-0653-10</NDC11Code>
<ProductNDC>40032-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206793</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>40032-653-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (40032-653-30) > 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>40032-0653-30</NDC11Code>
<ProductNDC>40032-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206793</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-653-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (43063-653-10) </PackageDescription>
<NDC11Code>43063-0653-10</NDC11Code>
<ProductNDC>43063-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201278</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52959-653-10</NDCCode>
<PackageDescription>10 CAPSULE, COATED in 1 BOTTLE, PLASTIC (52959-653-10)</PackageDescription>
<NDC11Code>52959-0653-10</NDC11Code>
<ProductNDC>52959-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065028</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin capsules, USP contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze, propylene glycol, simethicone, and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piper-azinyl)formimidoyl]-2,7-(epoxypentadeca-[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>57664-653-10</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (57664-653-10)</PackageDescription>
<NDC11Code>57664-0653-10</NDC11Code>
<ProductNDC>57664-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070772</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65862-653-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (65862-653-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10) </PackageDescription>
<NDC11Code>65862-0653-03</NDC11Code>
<ProductNDC>65862-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203175</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white, colored powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as modified caplet shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, hydroxy propyl cellulose, microcrystalline cellulose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65862-653-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65862-653-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-653-10) </PackageDescription>
<NDC11Code>65862-0653-78</NDC11Code>
<ProductNDC>65862-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203175</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride USP occurs as a white to off-white, colored powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as modified caplet shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride USP. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, hydroxy propyl cellulose, microcrystalline cellulose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>66267-653-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (66267-653-10) </PackageDescription>
<NDC11Code>66267-0653-10</NDC11Code>
<ProductNDC>66267-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<ProprietaryNameSuffix>Antihistamine</ProprietaryNameSuffix>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68001-653-17</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68001-653-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-653-16) </PackageDescription>
<NDC11Code>68001-0653-17</NDC11Code>
<ProductNDC>68001-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenatane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
</NDC>
<NDC>
<NDCCode>68382-653-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68382-653-10) </PackageDescription>
<NDC11Code>68382-0653-10</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>68382-653-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30) </PackageDescription>
<NDC11Code>68382-0653-77</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>70860-653-10</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (70860-653-10) > 10 mL in 1 VIAL (70860-653-41) </PackageDescription>
<NDC11Code>70860-0653-10</NDC11Code>
<ProductNDC>70860-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211504</ApplicationNumber>
<LabelerName>Athenex Pharmaceutical Division, LLC.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-653-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-10) </PackageDescription>
<NDC11Code>71205-0653-10</NDC11Code>
<ProductNDC>71205-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062676</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-653-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-653-10) </PackageDescription>
<NDC11Code>71919-0653-10</NDC11Code>
<ProductNDC>71919-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sulfur</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72485-653-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>72485-0653-10</NDC11Code>
<ProductNDC>72485-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loteprednol Etabonate</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20231024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215933</ApplicationNumber>
<LabelerName>ARMAS PHARMACEUTICALS INC.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.</IndicationAndUsage>
<Description>Loteprednol Etabonate Ophthalmic Suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Water for Injection and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>75936-653-02</NDCCode>
<PackageDescription>10 mL in 1 TUBE (75936-653-02) </PackageDescription>
<NDC11Code>75936-0653-02</NDC11Code>
<ProductNDC>75936-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Play Everyday Face Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Supergoop, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10; 5; 7.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63739-003-33</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0003-33</NDC11Code>
<ProductNDC>63739-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120628</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071457</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules, USP 7.5 mg, are for oral administration. 7.5 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>63739-004-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-004-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0004-10</NDC11Code>
<ProductNDC>63739-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089805</ApplicationNumber>
<LabelerName>McKesson Corporation</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>30; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-005-32</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-005-32) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0005-32</NDC11Code>
<ProductNDC>63739-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120302</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077565</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160111</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia. Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)] Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)]. Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Ziprasidone capsules, USP contains the active moiety, ziprasidone in the form of ziprasidone hydrochloride, USP salt. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone capsules, USP contain a hydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride USP is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, hydrochloride. The molecular formula is C 21H 21ClN 4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride USP is a light pink to pink colored powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg, 40 mg, 60 mg, and 80 mg capsules. Ziprasidone capsules, USP contain ziprasidone hydrochloride, USP, anhydrous lactose, magnesium stearate, polysorbate 80, povidone (PVK-30), pregelatinized starch and silicon dioxide. The components of the capsule shells are FD&C Blue #1, FD&C Red #3, gelatin, red iron oxide and titanium dioxide. The capsule shells are imprinted with black ink. The components of black ink (Black SW-9008/SW-9009) are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Ziprasidone capsules meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>63739-006-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-006-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0006-10</NDC11Code>
<ProductNDC>63739-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090635</ApplicationNumber>
<LabelerName>McKesson Corporation</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-007-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (63739-007-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0007-10</NDC11Code>
<ProductNDC>63739-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078220</ApplicationNumber>
<LabelerName>McKesson Corporation</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-008-33</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-008-33) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0008-33</NDC11Code>
<ProductNDC>63739-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160531</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206181</ApplicationNumber>
<LabelerName>Mckesson Corporation DBA SKY Packaginng</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160531</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis (1.1) Candidemia in non-neutropenics and other deep tissue Candida infections (1.2) Esophageal candidiasis (1.3) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4).</IndicationAndUsage>
<Description>Voriconazole USP, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (αR,βS)-α-(2,4-difluorophenyl)-5- fluoro- β -methyl- α -(1H-1,2,4-traizol-l-ylmethyl)-4-pyrimidineethanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.31 g/mole. Voriconazole drug substance is a white or almost white powder. Voriconazole tablets contain 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>63739-013-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-013-10) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0013-10</NDC11Code>
<ProductNDC>63739-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074260</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-014-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-014-10) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0014-10</NDC11Code>
<ProductNDC>63739-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170713</StartMarketingDatePackage>
<EndMarketingDatePackage>20210831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-015-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-015-10) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0015-10</NDC11Code>
<ProductNDC>63739-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170713</StartMarketingDatePackage>
<EndMarketingDatePackage>20210831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63739-016-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-016-10) / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0016-10</NDC11Code>
<ProductNDC>63739-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>McKesson Corporation dba SKY Packaging</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg or 300 mg diltiazem hydrochloride. Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
</NDCList>