{
"NDC": [
{
"NDCCode": "73190-013-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-013-01) ",
"NDC11Code": "73190-0013-01",
"ProductNDC": "73190-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215775",
"LabelerName": "AvKARE",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "73190-001-01",
"PackageDescription": "44.3 mL in 1 BOTTLE (73190-001-01) ",
"NDC11Code": "73190-0001-01",
"ProductNDC": "73190-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Waltz Free Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190813",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AvKARE",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".0013",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190813",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "73190-009-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (73190-009-01) ",
"NDC11Code": "73190-0009-01",
"ProductNDC": "73190-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090055",
"LabelerName": "AvKARE",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250425",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)]or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "73190-010-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (73190-010-01) ",
"NDC11Code": "73190-0010-01",
"ProductNDC": "73190-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolate Mofetil",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090456",
"LabelerName": "AvKARE",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250425",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)]or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "73190-011-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-011-01) ",
"NDC11Code": "73190-0011-01",
"ProductNDC": "73190-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215775",
"LabelerName": "AvKARE",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "73190-012-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-012-01) ",
"NDC11Code": "73190-0012-01",
"ProductNDC": "73190-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215775",
"LabelerName": "AvKARE",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "73190-026-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-026-01) ",
"NDC11Code": "73190-0026-01",
"ProductNDC": "73190-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074737",
"LabelerName": "AvKARE",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"Description": "Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-((2S)-3-mercapto-2-methylpropionyl)-L-proline (MW 217.29) and has the following structural formula. C 9H 15NO 3S. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and 100 mg of Captopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF and microcrystalline cellulose NF."
},
{
"NDCCode": "73190-027-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-027-01) ",
"NDC11Code": "73190-0027-01",
"ProductNDC": "73190-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074737",
"LabelerName": "AvKARE",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"Description": "Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-((2S)-3-mercapto-2-methylpropionyl)-L-proline (MW 217.29) and has the following structural formula. C 9H 15NO 3S. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and 100 mg of Captopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF and microcrystalline cellulose NF."
},
{
"NDCCode": "73190-028-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-028-01) ",
"NDC11Code": "73190-0028-01",
"ProductNDC": "73190-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074737",
"LabelerName": "AvKARE",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"Description": "Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-((2S)-3-mercapto-2-methylpropionyl)-L-proline (MW 217.29) and has the following structural formula. C 9H 15NO 3S. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and 100 mg of Captopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF and microcrystalline cellulose NF."
},
{
"NDCCode": "73190-029-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-029-01) ",
"NDC11Code": "73190-0029-01",
"ProductNDC": "73190-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040547",
"LabelerName": "AvKARE",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250424",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets are indicated: 1 In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "73190-030-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-030-01) ",
"NDC11Code": "73190-0030-01",
"ProductNDC": "73190-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040547",
"LabelerName": "AvKARE",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250424",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets are indicated: 1 In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "73190-037-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-037-01) ",
"NDC11Code": "73190-0037-01",
"ProductNDC": "73190-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086841",
"LabelerName": "AvKARE",
"SubstanceName": "DAPSONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "73190-064-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (73190-064-01) ",
"NDC11Code": "73190-0064-01",
"ProductNDC": "73190-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207724",
"LabelerName": "AvKARE",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251104",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C 21H 30O 2. Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide."
},
{
"NDCCode": "73190-065-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (73190-065-01) ",
"NDC11Code": "73190-0065-01",
"ProductNDC": "73190-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207724",
"LabelerName": "AvKARE",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251104",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C 21H 30O 2. Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide."
},
{
"NDCCode": "73190-068-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (73190-068-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "73190-0068-01",
"ProductNDC": "73190-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219254",
"LabelerName": "AvKARE",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "73190-081-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (73190-081-01) ",
"NDC11Code": "73190-0081-01",
"ProductNDC": "73190-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol Hydrochloride",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220865",
"LabelerName": "AvKARE",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260914",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C 14H 24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red."
},
{
"NDCCode": "73190-082-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (73190-082-01) ",
"NDC11Code": "73190-0082-01",
"ProductNDC": "73190-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol Hydrochloride",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220865",
"LabelerName": "AvKARE",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260914",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C 14H 24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red."
},
{
"NDCCode": "73190-083-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (73190-083-01) ",
"NDC11Code": "73190-0083-01",
"ProductNDC": "73190-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tapentadol Hydrochloride",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220865",
"LabelerName": "AvKARE",
"SubstanceName": "TAPENTADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260914",
"SamplePackage": "N",
"IndicationAndUsage": "Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C 14H 24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red."
},
{
"NDCCode": "73190-084-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-084-01) ",
"NDC11Code": "73190-0084-01",
"ProductNDC": "73190-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040547",
"LabelerName": "AvKARE",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "73190-085-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-085-01) ",
"NDC11Code": "73190-0085-01",
"ProductNDC": "73190-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040547",
"LabelerName": "AvKARE",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "73190-095-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (73190-095-01) ",
"NDC11Code": "73190-0095-01",
"ProductNDC": "73190-095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferiprone",
"NonProprietaryName": "Deferiprone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208800",
"LabelerName": "AvKARE",
"SubstanceName": "DEFERIPRONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260812",
"SamplePackage": "N",
"IndicationAndUsage": "Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate.",
"Description": "Deferiprone Tablets contain 1,000 mg or 500 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C 7H 9NO 2and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula:. Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272°C to 278°C."
},
{
"NDCCode": "73190-999-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (73190-999-01) ",
"NDC11Code": "73190-0999-01",
"ProductNDC": "73190-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexarotene",
"NonProprietaryName": "Bexarotene",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210105",
"LabelerName": "AvKARE",
"SubstanceName": "BEXAROTENE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241121",
"SamplePackage": "N",
"IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
"Description": "Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C 24H 28O 2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol 400, polysorbate 20 and povidone. The capsule shell contains gelatin, glycerin, purified water, sorbitol sorbitan solution, and titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze."
},
{
"NDCCode": "10702-013-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (10702-013-01) ",
"NDC11Code": "10702-0013-01",
"ProductNDC": "10702-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betaxolol Hydrochloride",
"NonProprietaryName": "Betaxolol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078962",
"LabelerName": "KVK-TECH, INC.",
"SubstanceName": "BETAXOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111102",
"SamplePackage": "N",
"IndicationAndUsage": "Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.",
"Description": "Betaxolol hydrochloride is a ß 1-selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure:. Each tablet for oral administration contains 10 mg or 20 mg of betaxolol hydrochloride equivalent to 8.94 mg or 17.88 mg of betaxolol respectively. In addition, each tablet contains the following inactive ingredients, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4."
},
{
"NDCCode": "10736-013-01",
"PackageDescription": "620 L in 1 CYLINDER (10736-013-01)",
"NDC11Code": "10736-0013-01",
"ProductNDC": "10736-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium Oxygen Mixture",
"NonProprietaryName": "Helium Oxygen Mixture",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Medical-technical Gases, Inc.",
"SubstanceName": "HELIUM; OXYGEN",
"StrengthNumber": "800; 200",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10812-013-01",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10812-013-01) > 4.2 g in 1 TUBE",
"NDC11Code": "10812-0013-01",
"ProductNDC": "10812-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Revitalizing Lip Balm",
"ProprietaryNameSuffix": "Spf 20 - Petal Glow 40",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"EndMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11534-013-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-013-01)",
"NDC11Code": "11534-0013-01",
"ProductNDC": "11534-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050708",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Sunrise Pharmaceutical Inc",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For temporary relief of occasional constipation and irregularity. This product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "11559-013-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (11559-013-01) > 50 mL in 1 BOTTLE (11559-013-02)",
"NDC11Code": "11559-0013-01",
"ProductNDC": "11559-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Resilience Lift",
"ProprietaryNameSuffix": "Firming Sculpting Face And Neck Spf15 Normal Combo Skin",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "7.5; 1.4",
"StrengthUnit": "mL/100mL; mL/100mL",
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{
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"PackageDescription": "100 TABLET in 1 BOTTLE (13107-013-01)",
"NDC11Code": "13107-0013-01",
"ProductNDC": "13107-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
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"IndicationAndUsage": "Major Depressive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride tablets were established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride tablets in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder. Sertraline hydrochloride tablets are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride tablets were established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride tablets in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD). Sertraline hydrochloride tablets are indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD). Sertraline hydrochloride tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride tablets in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder. Sertraline hydrochloride tablets are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride tablets in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride tablets treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY)."
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha Signature Wrinkle Filler Bb",
"ProprietaryNameSuffix": "Spf37 Pa Plus Plus No.23",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "CUTANEOUS",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
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"LabelerName": "ABLE C&C CO., LTD.",
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"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (13913-013-01) > 8 SPRAY in 1 BOTTLE, SPRAY",
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"ProductNDC": "13913-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lazanda",
"NonProprietaryName": "Fentanyl Citrate",
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"LabelerName": "Depomed, Inc.",
"SubstanceName": "FENTANYL CITRATE",
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"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Waltz Free Hand Sanitizer</ProprietaryName>
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<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.</Description>
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<Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23H 31NO 7, a molecular weight of 433.50, and the following structural formula:. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF. Inactive ingredients in mycophenolate mofetil capsules, USP 250 mg include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-30). The capsule shells contain FD&C red # 3, gelatin, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. Inactive ingredients in mycophenolate mofetil tablets, USP 500 mg include croscarmellose sodium, magnesium stearate (Vegetable), microcrystalline cellulose, opadry brown, povidone [K-30]. The opadry brown contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride Extended-release</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<LabelerName>AvKARE</LabelerName>
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<Status>Active</Status>
<LastUpdate>2025-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-012-01) </PackageDescription>
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<ProductNDC>73190-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride Extended-release</ProprietaryName>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>73190-026-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-026-01) </PackageDescription>
<NDC11Code>73190-0026-01</NDC11Code>
<ProductNDC>73190-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074737</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-((2S)-3-mercapto-2-methylpropionyl)-L-proline (MW 217.29) and has the following structural formula. C 9H 15NO 3S. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and 100 mg of Captopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF and microcrystalline cellulose NF.</Description>
</NDC>
<NDC>
<NDCCode>73190-027-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-027-01) </PackageDescription>
<NDC11Code>73190-0027-01</NDC11Code>
<ProductNDC>73190-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074737</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-((2S)-3-mercapto-2-methylpropionyl)-L-proline (MW 217.29) and has the following structural formula. C 9H 15NO 3S. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and 100 mg of Captopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF and microcrystalline cellulose NF.</Description>
</NDC>
<NDC>
<NDCCode>73190-028-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-028-01) </PackageDescription>
<NDC11Code>73190-0028-01</NDC11Code>
<ProductNDC>73190-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074737</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-((2S)-3-mercapto-2-methylpropionyl)-L-proline (MW 217.29) and has the following structural formula. C 9H 15NO 3S. Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg and 100 mg of Captopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide NF, croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF and microcrystalline cellulose NF.</Description>
</NDC>
<NDC>
<NDCCode>73190-029-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-029-01) </PackageDescription>
<NDC11Code>73190-0029-01</NDC11Code>
<ProductNDC>73190-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040547</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets are indicated: 1 In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>73190-030-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-030-01) </PackageDescription>
<NDC11Code>73190-0030-01</NDC11Code>
<ProductNDC>73190-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040547</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets are indicated: 1 In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>73190-037-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-037-01) </PackageDescription>
<NDC11Code>73190-0037-01</NDC11Code>
<ProductNDC>73190-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086841</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>73190-064-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (73190-064-01) </PackageDescription>
<NDC11Code>73190-0064-01</NDC11Code>
<ProductNDC>73190-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207724</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C 21H 30O 2. Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-065-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (73190-065-01) </PackageDescription>
<NDC11Code>73190-0065-01</NDC11Code>
<ProductNDC>73190-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207724</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone capsules contain progesterone, USP for oral administration. Progesterone, USP has a molecular weight of 314.47 and a molecular formula of C 21H 30O 2. Progesterone, USP (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:. Progesterone, USP is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain either 100 mg or 200 mg progesterone, USP. The inactive ingredients for progesterone capsules 100 mg and 200 mg include: arachis oil, D&C Yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, gelatin, glycerin, purified water, soy lecithin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-068-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (73190-068-01) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>73190-0068-01</NDC11Code>
<ProductNDC>73190-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219254</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>73190-081-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (73190-081-01) </PackageDescription>
<NDC11Code>73190-0081-01</NDC11Code>
<ProductNDC>73190-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220865</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C 14H 24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>73190-082-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (73190-082-01) </PackageDescription>
<NDC11Code>73190-0082-01</NDC11Code>
<ProductNDC>73190-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220865</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C 14H 24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>73190-083-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (73190-083-01) </PackageDescription>
<NDC11Code>73190-0083-01</NDC11Code>
<ProductNDC>73190-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tapentadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220865</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TAPENTADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is (3-[(lR,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl] phenol monohydrochloride) and it has the following chemical structure. The molecular weight of tapentadol hydrochloride is 257.8, and the molecular formula is C 14H 24ClNO. The n-octanol:water partition coefficient log P value is -1.32. The pKa value is 7.90. The inactive ingredients in tapentadol tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. The film coatings for all tablet strengths contain polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>73190-084-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-084-01) </PackageDescription>
<NDC11Code>73190-0084-01</NDC11Code>
<ProductNDC>73190-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040547</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>73190-085-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-085-01) </PackageDescription>
<NDC11Code>73190-0085-01</NDC11Code>
<ProductNDC>73190-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040547</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>73190-095-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73190-095-01) </PackageDescription>
<NDC11Code>73190-0095-01</NDC11Code>
<ProductNDC>73190-095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferiprone</ProprietaryName>
<NonProprietaryName>Deferiprone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208800</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DEFERIPRONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate.</IndicationAndUsage>
<Description>Deferiprone Tablets contain 1,000 mg or 500 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C 7H 9NO 2and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula:. Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272°C to 278°C.</Description>
</NDC>
<NDC>
<NDCCode>73190-999-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (73190-999-01) </PackageDescription>
<NDC11Code>73190-0999-01</NDC11Code>
<ProductNDC>73190-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexarotene</ProprietaryName>
<NonProprietaryName>Bexarotene</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210105</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>BEXAROTENE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.</IndicationAndUsage>
<Description>Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C 24H 28O 2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, polyethylene glycol 400, polysorbate 20 and povidone. The capsule shell contains gelatin, glycerin, purified water, sorbitol sorbitan solution, and titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>10702-013-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (10702-013-01) </PackageDescription>
<NDC11Code>10702-0013-01</NDC11Code>
<ProductNDC>10702-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betaxolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Betaxolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078962</ApplicationNumber>
<LabelerName>KVK-TECH, INC.</LabelerName>
<SubstanceName>BETAXOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.</IndicationAndUsage>
<Description>Betaxolol hydrochloride is a ß 1-selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure:. Each tablet for oral administration contains 10 mg or 20 mg of betaxolol hydrochloride equivalent to 8.94 mg or 17.88 mg of betaxolol respectively. In addition, each tablet contains the following inactive ingredients, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4.</Description>
</NDC>
<NDC>
<NDCCode>10736-013-01</NDCCode>
<PackageDescription>620 L in 1 CYLINDER (10736-013-01)</PackageDescription>
<NDC11Code>10736-0013-01</NDC11Code>
<ProductNDC>10736-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium Oxygen Mixture</ProprietaryName>
<NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Medical-technical Gases, Inc.</LabelerName>
<SubstanceName>HELIUM; OXYGEN</SubstanceName>
<StrengthNumber>800; 200</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10812-013-01</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (10812-013-01) > 4.2 g in 1 TUBE</PackageDescription>
<NDC11Code>10812-0013-01</NDC11Code>
<ProductNDC>10812-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Revitalizing Lip Balm</ProprietaryName>
<ProprietaryNameSuffix>Spf 20 - Petal Glow 40</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11534-013-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (11534-013-01)</PackageDescription>
<NDC11Code>11534-0013-01</NDC11Code>
<ProductNDC>11534-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050708</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Sunrise Pharmaceutical Inc</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For temporary relief of occasional constipation and irregularity. This product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11559-013-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11559-013-01) > 50 mL in 1 BOTTLE (11559-013-02)</PackageDescription>
<NDC11Code>11559-0013-01</NDC11Code>
<ProductNDC>11559-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Resilience Lift</ProprietaryName>
<ProprietaryNameSuffix>Firming Sculpting Face And Neck Spf15 Normal Combo Skin</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7.5; 1.4</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13107-013-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-013-01)</PackageDescription>
<NDC11Code>13107-0013-01</NDC11Code>
<ProductNDC>13107-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride tablets were established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride tablets in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder. Sertraline hydrochloride tablets are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride tablets were established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride tablets in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD). Sertraline hydrochloride tablets are indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD). Sertraline hydrochloride tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride tablets in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder. Sertraline hydrochloride tablets are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride tablets in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride tablets treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).</IndicationAndUsage>
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