{
"NDC": [
{
"NDCCode": "47781-475-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-475-74) > 1 FILM in 1 POUCH (47781-475-11) ",
"NDC11Code": "47781-0475-74",
"ProductNDC": "47781-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "900",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
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{
"NDCCode": "47781-400-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-400-74) > 1 FILM in 1 POUCH (47781-400-11) ",
"NDC11Code": "47781-0400-74",
"ProductNDC": "47781-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
},
{
"NDCCode": "47781-425-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-425-74) > 1 FILM in 1 POUCH (47781-425-11) ",
"NDC11Code": "47781-0425-74",
"ProductNDC": "47781-425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
},
{
"NDCCode": "47781-471-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-471-74) > 1 FILM in 1 POUCH (47781-471-11) ",
"NDC11Code": "47781-0471-74",
"ProductNDC": "47781-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
},
{
"NDCCode": "47781-472-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-472-74) > 1 FILM in 1 POUCH (47781-472-11) ",
"NDC11Code": "47781-0472-74",
"ProductNDC": "47781-472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
},
{
"NDCCode": "47781-473-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-473-74) > 1 FILM in 1 POUCH (47781-473-11) ",
"NDC11Code": "47781-0473-74",
"ProductNDC": "47781-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
},
{
"NDCCode": "47781-474-74",
"PackageDescription": "60 POUCH in 1 CARTON (47781-474-74) > 1 FILM in 1 POUCH (47781-474-11) ",
"NDC11Code": "47781-0474-74",
"ProductNDC": "47781-474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Buccal Film",
"NonProprietaryName": "Buprenorphine Buccal",
"DosageFormName": "FILM",
"RouteName": "BUCCAL",
"StartMarketingDate": "20210804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211594",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210804",
"SamplePackage": "N"
},
{
"NDCCode": "13668-189-74",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74) ",
"NDC11Code": "13668-0189-74",
"ProductNDC": "13668-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203016",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150811",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1).",
"Description": "Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate, USP is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate 4 mg extended-release capsules, USP for oral administration contain 4 mg of tolterodine tartrate, USP. Inactive ingredients are cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Tolterodine tartrate 2 mg extended-release capsules, USP for oral administration contain 2 mg of tolterodine tartrate, USP, and the following inactive ingredients: cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, iron oxide yellow, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "13668-190-74",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-190-74) ",
"NDC11Code": "13668-0190-74",
"ProductNDC": "13668-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203016",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150811",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1).",
"Description": "Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate, USP is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate 4 mg extended-release capsules, USP for oral administration contain 4 mg of tolterodine tartrate, USP. Inactive ingredients are cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Tolterodine tartrate 2 mg extended-release capsules, USP for oral administration contain 2 mg of tolterodine tartrate, USP, and the following inactive ingredients: cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, iron oxide yellow, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "76420-475-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (76420-475-01) ",
"NDC11Code": "76420-0475-01",
"ProductNDC": "76420-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-475-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (76420-475-05) ",
"NDC11Code": "76420-0475-05",
"ProductNDC": "76420-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-475-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (76420-475-30) ",
"NDC11Code": "76420-0475-30",
"ProductNDC": "76420-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-475-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (76420-475-60) ",
"NDC11Code": "76420-0475-60",
"ProductNDC": "76420-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "76420-475-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-475-90) ",
"NDC11Code": "76420-0475-90",
"ProductNDC": "76420-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "47781-011-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-011-01) ",
"NDC11Code": "47781-0011-01",
"ProductNDC": "47781-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL; SUBLINGUAL",
"StartMarketingDate": "20220307",
"EndMarketingDate": "20251201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220307",
"EndMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine Sulfate Sublingual Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Sublingual Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Sublingual Tablets contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol and flavor."
},
{
"NDCCode": "47781-012-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47781-012-01) ",
"NDC11Code": "47781-0012-01",
"ProductNDC": "47781-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20220307",
"EndMarketingDate": "20250901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220307",
"EndMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Orally Disintegrating Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol and flavor."
},
{
"NDCCode": "47781-013-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (47781-013-01) ",
"NDC11Code": "47781-0013-01",
"ProductNDC": "47781-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"EndMarketingDate": "20251101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220126",
"EndMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "47781-014-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-014-01) ",
"NDC11Code": "47781-0014-01",
"ProductNDC": "47781-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyoscyamine Sulfate",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20250901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".375",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine Sulfate Extended-Release Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Extended-Release Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "47781-100-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (47781-100-60)",
"NDC11Code": "47781-0100-60",
"ProductNDC": "47781-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203176",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "47781-103-21",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (47781-103-21) / 3 TABLET in 1 BLISTER PACK",
"NDC11Code": "47781-0103-21",
"ProductNDC": "47781-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibandronate Sodium",
"NonProprietaryName": "Ibandronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078998",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "IBANDRONATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191218",
"SamplePackage": "N",
"Description": "Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na·H2O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula. Ibandronate sodium is available as a yellow colored capsule shaped 150 mg film-coated tablet as ibandronic acid for once-monthly oral administration. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. Ibandronate sodium tablet also contains the following inactive ingredients: lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, opadry yellow and purified water. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000 and iron oxide yellow."
},
{
"NDCCode": "47781-103-33",
"PackageDescription": "3 BLISTER PACK in 1 BOX (47781-103-33) / 1 TABLET in 1 BLISTER PACK (47781-103-07) ",
"NDC11Code": "47781-0103-33",
"ProductNDC": "47781-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibandronate Sodium",
"NonProprietaryName": "Ibandronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078998",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "IBANDRONATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20140501",
"SamplePackage": "N",
"Description": "Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na·H2O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula. Ibandronate sodium is available as a yellow colored capsule shaped 150 mg film-coated tablet as ibandronic acid for once-monthly oral administration. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. Ibandronate sodium tablet also contains the following inactive ingredients: lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, opadry yellow and purified water. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000 and iron oxide yellow."
},
{
"NDCCode": "47781-104-44",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "47781-0104-44",
"ProductNDC": "47781-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20180305",
"EndMarketingDate": "20270601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209767",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "ESTRADIOL HEMIHYDRATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180625",
"EndMarketingDatePackage": "20270601",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.",
"Description": "Each gram of estradiol vaginal cream, USP, 0.01% contains 0.1 mg estradiol (as estradiol hemihydrate) in a nonliquefying base containing propylene glycol, methylparaben, sodium lauryl sulfate, mono- and di-glycerides, stearyl alcohol, ceresin wax, tert-butylhydroquinone, disodium EDTA, hypromellose, and purified water. Estradiol hemihydrate is chemically described as estra-1,3,5(10)-triene-3,17β-diol hemihydrate. It has an empirical formula of C18H24O2 . ½H2O and molecular weight of 272.37. The structural formula is:."
},
{
"NDCCode": "47781-108-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (47781-108-30) ",
"NDC11Code": "47781-0108-30",
"ProductNDC": "47781-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exemestane",
"NonProprietaryName": "Exemestane",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140725",
"EndMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200898",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "EXEMESTANE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140725",
"EndMarketingDatePackage": "20221201",
"SamplePackage": "N"
},
{
"NDCCode": "47781-135-34",
"PackageDescription": "1 VIAL in 1 CARTON (47781-135-34) > 10 mL in 1 VIAL",
"NDC11Code": "47781-0135-34",
"ProductNDC": "47781-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml",
"ProprietaryNameSuffix": "Ophthalmic Solution 2%, 10ml",
"NonProprietaryName": "Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091034",
"LabelerName": "ALVOGEN INC.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
"StrengthNumber": "22.3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "47781-136-34",
"PackageDescription": "1 VIAL in 1 CARTON (47781-136-34) > 10 mL in 1 VIAL",
"NDC11Code": "47781-0136-34",
"ProductNDC": "47781-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution",
"ProprietaryNameSuffix": "Sterile Ophthalmic Solution",
"NonProprietaryName": "Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091180",
"LabelerName": "ALVOGEN INC.",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "22.3; 6.8",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "47781-137-36",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (47781-137-36) > 5 mL in 1 BOTTLE, DROPPER",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Olopatadine Hydrochloride Usp, 0.1%",
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"ApplicationNumber": "ANDA204706",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "47781-138-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (47781-138-30) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"EndMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Alvogen, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]",
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"LastUpdate": "2020-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161219",
"EndMarketingDatePackage": "20200901",
"SamplePackage": "N"
},
{
"NDCCode": "47781-139-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (47781-139-30) ",
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"ProductNDC": "47781-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Alvogen, Inc.",
"SubstanceName": "RASAGILINE MESYLATE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161219",
"EndMarketingDatePackage": "20201001",
"SamplePackage": "N"
},
{
"NDCCode": "47781-146-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47781-146-01) ",
"NDC11Code": "47781-0146-01",
"ProductNDC": "47781-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Budesonide (enteric Coated)",
"NonProprietaryName": "Budesonide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20161123",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206724",
"LabelerName": "Alvogen, Inc.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161128",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "47781-147-20",
"PackageDescription": "20 CARTON in 1 BOX (47781-147-20) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "47781-0147-20",
"ProductNDC": "47781-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gadopentetate Dimeglumine",
"NonProprietaryName": "Gadopentetate Dimeglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140224",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019596",
"LabelerName": "Alvogen, Inc",
"SubstanceName": "GADOPENTETATE DIMEGLUMINE",
"StrengthNumber": "469.01",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<NDCCode>47781-475-74</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (47781-475-74) > 1 FILM in 1 POUCH (47781-475-11) </PackageDescription>
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<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>60 POUCH in 1 CARTON (47781-400-74) > 1 FILM in 1 POUCH (47781-400-11) </PackageDescription>
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<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
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<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>47781-425-74</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (47781-425-74) > 1 FILM in 1 POUCH (47781-425-11) </PackageDescription>
<NDC11Code>47781-0425-74</NDC11Code>
<ProductNDC>47781-425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-471-74</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (47781-471-74) > 1 FILM in 1 POUCH (47781-471-11) </PackageDescription>
<NDC11Code>47781-0471-74</NDC11Code>
<ProductNDC>47781-471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Buccal Film</ProprietaryName>
<NonProprietaryName>Buprenorphine Buccal</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
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<StartMarketingDate>20210804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211594</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>47781-472-74</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (47781-472-74) > 1 FILM in 1 POUCH (47781-472-11) </PackageDescription>
<NDC11Code>47781-0472-74</NDC11Code>
<ProductNDC>47781-472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Buccal Film</ProprietaryName>
<NonProprietaryName>Buprenorphine Buccal</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20210804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211594</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>47781-473-74</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (47781-473-74) > 1 FILM in 1 POUCH (47781-473-11) </PackageDescription>
<NDC11Code>47781-0473-74</NDC11Code>
<ProductNDC>47781-473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Buccal Film</ProprietaryName>
<NonProprietaryName>Buprenorphine Buccal</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20210804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211594</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>47781-474-74</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (47781-474-74) > 1 FILM in 1 POUCH (47781-474-11) </PackageDescription>
<NDC11Code>47781-0474-74</NDC11Code>
<ProductNDC>47781-474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Buccal Film</ProprietaryName>
<NonProprietaryName>Buprenorphine Buccal</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>BUCCAL</RouteName>
<StartMarketingDate>20210804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211594</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-189-74</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74) </PackageDescription>
<NDC11Code>13668-0189-74</NDC11Code>
<ProductNDC>13668-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203016</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1).</IndicationAndUsage>
<Description>Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate, USP is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate 4 mg extended-release capsules, USP for oral administration contain 4 mg of tolterodine tartrate, USP. Inactive ingredients are cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Tolterodine tartrate 2 mg extended-release capsules, USP for oral administration contain 2 mg of tolterodine tartrate, USP, and the following inactive ingredients: cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, iron oxide yellow, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>13668-190-74</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-190-74) </PackageDescription>
<NDC11Code>13668-0190-74</NDC11Code>
<ProductNDC>13668-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203016</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1).</IndicationAndUsage>
<Description>Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate, USP is (R)-N, N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate, USP is a white, crystalline powder with a molecular weight of 475.6. The pK a value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate 4 mg extended-release capsules, USP for oral administration contain 4 mg of tolterodine tartrate, USP. Inactive ingredients are cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Tolterodine tartrate 2 mg extended-release capsules, USP for oral administration contain 2 mg of tolterodine tartrate, USP, and the following inactive ingredients: cellulose microcrystalline, ethyl cellulose, FD & C blue 2, gelatin, hypromellose, iron oxide yellow, medium chain triglycerides, oleic acid, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>76420-475-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (76420-475-01) </PackageDescription>
<NDC11Code>76420-0475-01</NDC11Code>
<ProductNDC>76420-475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071457</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
</NDC>
<NDC>
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<PackageDescription>500 CAPSULE in 1 BOTTLE (76420-475-05) </PackageDescription>
<NDC11Code>76420-0475-05</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>19870421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
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<LastUpdate>2025-10-09</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<LabelerName>Asclemed USA, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
</NDC>
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<NDCCode>76420-475-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (76420-475-90) </PackageDescription>
<NDC11Code>76420-0475-90</NDC11Code>
<ProductNDC>76420-475</ProductNDC>
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<ProprietaryName>Temazepam</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19870421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071457</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C 16H 13ClN 2O 2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients:Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include:sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
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<NDC>
<NDCCode>47781-011-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-011-01) </PackageDescription>
<NDC11Code>47781-0011-01</NDC11Code>
<ProductNDC>47781-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20220307</StartMarketingDate>
<EndMarketingDate>20251201</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<EndMarketingDatePackage>20251201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Sublingual Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Sublingual Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Sublingual Tablets contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol and flavor.</Description>
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<NDCCode>47781-012-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47781-012-01) </PackageDescription>
<NDC11Code>47781-0012-01</NDC11Code>
<ProductNDC>47781-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<EndMarketingDate>20250901</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<EndMarketingDatePackage>20250901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Orally Disintegrating Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol and flavor.</Description>
</NDC>
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<NDCCode>47781-013-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (47781-013-01) </PackageDescription>
<NDC11Code>47781-0013-01</NDC11Code>
<ProductNDC>47781-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<EndMarketingDate>20251101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<EndMarketingDatePackage>20251101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Tablets, USP are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
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<NDCCode>47781-014-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-014-01) </PackageDescription>
<NDC11Code>47781-0014-01</NDC11Code>
<ProductNDC>47781-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamine Sulfate</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220131</StartMarketingDate>
<EndMarketingDate>20250901</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220131</StartMarketingDatePackage>
<EndMarketingDatePackage>20250901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine Sulfate Extended-Release Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Extended-Release Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2H2SO42H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>47781-100-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (47781-100-60)</PackageDescription>
<NDC11Code>47781-0100-60</NDC11Code>
<ProductNDC>47781-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203176</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-103-21</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (47781-103-21) / 3 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47781-0103-21</NDC11Code>
<ProductNDC>47781-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibandronate Sodium</ProprietaryName>
<NonProprietaryName>Ibandronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078998</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>IBANDRONATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na·H2O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula. Ibandronate sodium is available as a yellow colored capsule shaped 150 mg film-coated tablet as ibandronic acid for once-monthly oral administration. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. Ibandronate sodium tablet also contains the following inactive ingredients: lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, opadry yellow and purified water. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000 and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>47781-103-33</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (47781-103-33) / 1 TABLET in 1 BLISTER PACK (47781-103-07) </PackageDescription>
<NDC11Code>47781-0103-33</NDC11Code>
<ProductNDC>47781-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibandronate Sodium</ProprietaryName>
<NonProprietaryName>Ibandronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078998</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>IBANDRONATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na·H2O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula. Ibandronate sodium is available as a yellow colored capsule shaped 150 mg film-coated tablet as ibandronic acid for once-monthly oral administration. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. Ibandronate sodium tablet also contains the following inactive ingredients: lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, opadry yellow and purified water. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000 and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>47781-104-44</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>47781-0104-44</NDC11Code>
<ProductNDC>47781-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20180305</StartMarketingDate>
<EndMarketingDate>20270601</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209767</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>ESTRADIOL HEMIHYDRATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180625</StartMarketingDatePackage>
<EndMarketingDatePackage>20270601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.</IndicationAndUsage>
<Description>Each gram of estradiol vaginal cream, USP, 0.01% contains 0.1 mg estradiol (as estradiol hemihydrate) in a nonliquefying base containing propylene glycol, methylparaben, sodium lauryl sulfate, mono- and di-glycerides, stearyl alcohol, ceresin wax, tert-butylhydroquinone, disodium EDTA, hypromellose, and purified water. Estradiol hemihydrate is chemically described as estra-1,3,5(10)-triene-3,17β-diol hemihydrate. It has an empirical formula of C18H24O2 . ½H2O and molecular weight of 272.37. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>47781-108-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (47781-108-30) </PackageDescription>
<NDC11Code>47781-0108-30</NDC11Code>
<ProductNDC>47781-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exemestane</ProprietaryName>
<NonProprietaryName>Exemestane</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140725</StartMarketingDate>
<EndMarketingDate>20221201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200898</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>EXEMESTANE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140725</StartMarketingDatePackage>
<EndMarketingDatePackage>20221201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-135-34</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (47781-135-34) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>47781-0135-34</NDC11Code>
<ProductNDC>47781-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml</ProprietaryName>
<ProprietaryNameSuffix>Ophthalmic Solution 2%, 10ml</ProprietaryNameSuffix>
<NonProprietaryName>Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10ml</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091034</ApplicationNumber>
<LabelerName>ALVOGEN INC.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>22.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-136-34</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (47781-136-34) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>47781-0136-34</NDC11Code>
<ProductNDC>47781-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution</ProprietaryName>
<ProprietaryNameSuffix>Sterile Ophthalmic Solution</ProprietaryNameSuffix>
<NonProprietaryName>Dorzolamide Hydrochloride-timolol Maleate Ophthalmic Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091180</ApplicationNumber>
<LabelerName>ALVOGEN INC.</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>22.3; 6.8</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-137-36</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (47781-137-36) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>47781-0137-36</NDC11Code>
<ProductNDC>47781-137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olopatadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride Usp, 0.1%</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20151208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204706</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47781-138-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (47781-138-30) </PackageDescription>
<NDC11Code>47781-0138-30</NDC11Code>
<ProductNDC>47781-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasagiline Mesylate</ProprietaryName>
<NonProprietaryName>Rasagiline Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161219</StartMarketingDate>
<EndMarketingDate>20200901</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201970</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161219</StartMarketingDatePackage>
<EndMarketingDatePackage>20200901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-139-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (47781-139-30) </PackageDescription>
<NDC11Code>47781-0139-30</NDC11Code>
<ProductNDC>47781-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasagiline Mesylate</ProprietaryName>
<NonProprietaryName>Rasagiline Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161219</StartMarketingDate>
<EndMarketingDate>20201001</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201970</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161219</StartMarketingDatePackage>
<EndMarketingDatePackage>20201001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-146-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47781-146-01) </PackageDescription>
<NDC11Code>47781-0146-01</NDC11Code>
<ProductNDC>47781-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide (enteric Coated)</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161123</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206724</ApplicationNumber>
<LabelerName>Alvogen, Inc.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47781-147-20</NDCCode>
<PackageDescription>20 CARTON in 1 BOX (47781-147-20) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>47781-0147-20</NDC11Code>
<ProductNDC>47781-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gadopentetate Dimeglumine</ProprietaryName>
<NonProprietaryName>Gadopentetate Dimeglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140224</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019596</ApplicationNumber>
<LabelerName>Alvogen, Inc</LabelerName>
<SubstanceName>GADOPENTETATE DIMEGLUMINE</SubstanceName>
<StrengthNumber>469.01</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>