{
"NDC": [
{
"NDCCode": "43975-254-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, GLASS (43975-254-14) ",
"NDC11Code": "43975-0254-14",
"ProductNDC": "43975-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N"
},
{
"NDCCode": "43975-254-05",
"PackageDescription": "5 CAPSULE in 1 BOTTLE, GLASS (43975-254-05) ",
"NDC11Code": "43975-0254-05",
"ProductNDC": "43975-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N"
},
{
"NDCCode": "50458-254-14",
"PackageDescription": "5 AMPULE in 1 BOX (50458-254-14) / 1 mL in 1 AMPULE",
"NDC11Code": "50458-0254-14",
"ProductNDC": "50458-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haldol Decanoate",
"NonProprietaryName": "Haloperidol Decanoate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19860114",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018701",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "HALOPERIDOL DECANOATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19860114",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "HALDOL DECANOATE is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.",
"Description": "HALDOL DECANOATE (haloperidol decanoate injection) is the decanoate ester of haloperidol, for intramuscular use. Haloperidol is a typical antipsychotic. The structural formula of haloperidol decanoate is 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl] piperidin-4-yl decanoate. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL) but is soluble in most organic solvents. Each mL of HALDOL DECANOATE contains: 1 50 mg of haloperidol (present as 70.5 mg of haloperidol decanoate) in a sesame oil vehicle (0.85 g/mL), with 15 mg/mL benzyl alcohol as a preservative., 2 100 mg of haloperidol (present as 141 mg of haloperidol decanoate) in a sesame oil vehicle (0.85 g/mL), with 15 mg/mL benzyl alcohol as a preservative."
},
{
"NDCCode": "62932-254-33",
"PackageDescription": "14 g in 1 CONTAINER (62932-254-33) ",
"NDC11Code": "62932-0254-33",
"ProductNDC": "62932-254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Two Peas Mineral Spf 30 Sunstick",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Private Label Select Ltd CO",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N"
},
{
"NDCCode": "43975-252-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, GLASS (43975-252-14) ",
"NDC11Code": "43975-0252-14",
"ProductNDC": "43975-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N"
},
{
"NDCCode": "43975-253-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, GLASS (43975-253-14) ",
"NDC11Code": "43975-0253-14",
"ProductNDC": "43975-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N"
},
{
"NDCCode": "43975-255-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, GLASS (43975-255-14) ",
"NDC11Code": "43975-0255-14",
"ProductNDC": "43975-255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N"
},
{
"NDCCode": "43975-256-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, GLASS (43975-256-14) ",
"NDC11Code": "43975-0256-14",
"ProductNDC": "43975-256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160713",
"SamplePackage": "N"
},
{
"NDCCode": "43975-264-03",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-264-03) ",
"NDC11Code": "43975-0264-03",
"ProductNDC": "43975-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205365",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200519",
"SamplePackage": "N"
},
{
"NDCCode": "43975-264-09",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-264-09) ",
"NDC11Code": "43975-0264-09",
"ProductNDC": "43975-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205365",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200519",
"SamplePackage": "N"
},
{
"NDCCode": "43975-322-03",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-03) ",
"NDC11Code": "43975-0322-03",
"ProductNDC": "43975-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204562",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .",
"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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43975-322-09",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-09) ",
"NDC11Code": "43975-0322-09",
"ProductNDC": "43975-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204562",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .",
"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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43975-322-50",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-50) ",
"NDC11Code": "43975-0322-50",
"ProductNDC": "43975-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204562",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .",
"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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43975-323-03",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03) ",
"NDC11Code": "43975-0323-03",
"ProductNDC": "43975-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204562",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .",
"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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43975-323-09",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09) ",
"NDC11Code": "43975-0323-09",
"ProductNDC": "43975-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204562",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .",
"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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43975-323-50",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50) ",
"NDC11Code": "43975-0323-50",
"ProductNDC": "43975-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204562",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .",
"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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43975-349-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-349-03) ",
"NDC11Code": "43975-0349-03",
"ProductNDC": "43975-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204452",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery."
},
{
"NDCCode": "43975-350-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03) ",
"NDC11Code": "43975-0350-03",
"ProductNDC": "43975-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204452",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery."
},
{
"NDCCode": "43975-351-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-351-03) ",
"NDC11Code": "43975-0351-03",
"ProductNDC": "43975-351",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204452",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery."
},
{
"NDCCode": "43975-352-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-352-03) ",
"NDC11Code": "43975-0352-03",
"ProductNDC": "43975-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204452",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery."
},
{
"NDCCode": "0078-0867-42",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14) ",
"NDC11Code": "00078-0867-42",
"ProductNDC": "0078-0867",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kisqali",
"NonProprietaryName": "Ribociclib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170313",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209092",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "RIBOCICLIB SUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170313",
"SamplePackage": "N",
"IndicationAndUsage": "KISQALI is a kinase inhibitor indicated: 1 in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. (1), 2 for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; orfulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. (1).",
"Description": "KISQALI (ribociclib) is a kinase inhibitor. The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1). Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The molecular formula for ribociclib succinate is C23H30N8O·C4H6O4 and the molecular weight is 552.64 g/mol (Free base: 434.55 g/mol). The chemical structure of ribociclib is shown below. KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum as inactive ingredients."
},
{
"NDCCode": "0078-0916-61",
"PackageDescription": "1 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14) ",
"NDC11Code": "00078-0916-61",
"ProductNDC": "0078-0916",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kisqali Femara Co-pack",
"NonProprietaryName": "Letrozole And Ribociclib",
"DosageFormName": "KIT",
"StartMarketingDate": "20170504",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209935",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170504",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. (1), 2 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).",
"Description": "KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1). The molecular formula for ribociclib succinate is C23H30N8O.C4H6O4 and the molecular weight is 552.64 g/mol [Free base: 434.55 g/mol]. The chemical structure of ribociclib is shown below. KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "0178-0460-04",
"PackageDescription": "10 TUBE in 1 CARTON (0178-0460-04) / 4 g in 1 TUBE",
"NDC11Code": "00178-0460-04",
"ProductNDC": "0178-0460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avar-e Green",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110915",
"SamplePackage": "Y",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, chromium oxide green, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "0178-0465-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0178-0465-02) / 57 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "00178-0465-02",
"ProductNDC": "0178-0465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avar-e Ls",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110915",
"SamplePackage": "N",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "0178-0465-04",
"PackageDescription": "10 TUBE in 1 CARTON (0178-0465-04) / 4 g in 1 TUBE",
"NDC11Code": "00178-0465-04",
"ProductNDC": "0178-0465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avar-e Ls",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110915",
"SamplePackage": "Y",
"IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "0178-0495-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0178-0495-02) / 57 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "00178-0495-02",
"ProductNDC": "0178-0495",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ovaceplus",
"ProprietaryNameSuffix": "Plus",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110915",
"SamplePackage": "N",
"IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "0178-0495-04",
"PackageDescription": "10 TUBE in 1 CARTON (0178-0495-04) / 4 g in 1 TUBE",
"NDC11Code": "00178-0495-04",
"ProductNDC": "0178-0495",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ovaceplus",
"ProprietaryNameSuffix": "Plus",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110915",
"SamplePackage": "Y",
"IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
"Description": "Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "21695-254-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (21695-254-90)",
"NDC11Code": "21695-0254-90",
"ProductNDC": "21695-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077712",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "42192-129-16",
"PackageDescription": "480 mL in 1 BOTTLE (42192-129-16) ",
"NDC11Code": "42192-0129-16",
"ProductNDC": "42192-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide",
"NonProprietaryName": "Sodium Sulfacetamide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110104",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110104",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
"Description": "Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Each mL of Sodium Sulfacetamide 10% Wash contains 100 mg of sodium sulfacetamide, USP in a formulation containing cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glyerides, PEG-60 almond triglyceride, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate and sodium thiosulfate. Sodium Sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
},
{
"NDCCode": "42192-147-08",
"PackageDescription": "227 g in 1 BOTTLE (42192-147-08) ",
"NDC11Code": "42192-0147-08",
"ProductNDC": "42192-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide 10 Sulfur 2 Cleanser",
"NonProprietaryName": "Sulfacetamide Sodium And Sulfur",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140814",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140814",
"SamplePackage": "N",
"IndicationAndUsage": "SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
"Description": "Each gram of SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of sulfur in a base containing: BHT, cetyl alcohol, disodium edta, glyceryl stearate, lactic acid, magnesium aluminum silicate, methylparaben, PEG-100 stearate, petrolatum, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:."
}
]
}
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<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
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<ProductNDC>50458-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haldol Decanoate</ProprietaryName>
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<EndMarketingDate>20270831</EndMarketingDate>
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<StrengthUnit>mg/mL</StrengthUnit>
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<IndicationAndUsage>HALDOL DECANOATE is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.</IndicationAndUsage>
<Description>HALDOL DECANOATE (haloperidol decanoate injection) is the decanoate ester of haloperidol, for intramuscular use. Haloperidol is a typical antipsychotic. The structural formula of haloperidol decanoate is 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl] piperidin-4-yl decanoate. The molecular formula is C 31H 41CIFNO 3and has a molecular weight of 530.12. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL) but is soluble in most organic solvents. Each mL of HALDOL DECANOATE contains: 1 50 mg of haloperidol (present as 70.5 mg of haloperidol decanoate) in a sesame oil vehicle (0.85 g/mL), with 15 mg/mL benzyl alcohol as a preservative., 2 100 mg of haloperidol (present as 141 mg of haloperidol decanoate) in a sesame oil vehicle (0.85 g/mL), with 15 mg/mL benzyl alcohol as a preservative.</Description>
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<ProductNDC>62932-254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Two Peas Mineral Spf 30 Sunstick</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Private Label Select Ltd CO</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
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<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>14 CAPSULE in 1 BOTTLE, GLASS (43975-252-14) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203490</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
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<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
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<LastUpdate>2021-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20200519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205365</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-264-09) </PackageDescription>
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<ProductNDC>43975-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-03) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204562</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</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>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<NDC>
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<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<NDCCode>43975-322-50</NDCCode>
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<ProductNDC>43975-322</ProductNDC>
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<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<NDC11Code>43975-0323-03</NDC11Code>
<ProductNDC>43975-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>ANI Pharmaceuticals, Inc.</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>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
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<NDCCode>43975-323-09</NDCCode>
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<NDC11Code>43975-0323-09</NDC11Code>
<ProductNDC>43975-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
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<LabelerName>ANI Pharmaceuticals, Inc.</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>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
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<NDCCode>43975-323-50</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50) </PackageDescription>
<NDC11Code>43975-0323-50</NDC11Code>
<ProductNDC>43975-323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
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<StartMarketingDate>20190829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204562</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</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>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)] .</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 is (R)-N,N-diisopropyl-3-(2-hydroxy-5methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C 26H 37NO 7, Its structure is:. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pK avalue 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 extended-release capsules 4 mg for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. Tolterodine tartrate extended-release capsules 2 mg for oral administration contains 2 mg of tolterodine tartrate, and the following Inactive ingredients are colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, iron oxide yellow, sucrose, talc and titanium dioxide. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>43975-349-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-349-03) </PackageDescription>
<NDC11Code>43975-0349-03</NDC11Code>
<ProductNDC>43975-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204452</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery.</Description>
</NDC>
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<ProductNDC>43975-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204452</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery.</Description>
</NDC>
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<NDCCode>43975-351-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-351-03) </PackageDescription>
<NDC11Code>43975-0351-03</NDC11Code>
<ProductNDC>43975-351</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204452</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery.</Description>
</NDC>
<NDC>
<NDCCode>43975-352-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-352-03) </PackageDescription>
<NDC11Code>43975-0352-03</NDC11Code>
<ProductNDC>43975-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204452</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery.</Description>
</NDC>
<NDC>
<NDCCode>0078-0867-42</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0078-0867-42) / 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14) </PackageDescription>
<NDC11Code>00078-0867-42</NDC11Code>
<ProductNDC>0078-0867</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kisqali</ProprietaryName>
<NonProprietaryName>Ribociclib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170313</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209092</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>RIBOCICLIB SUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KISQALI is a kinase inhibitor indicated: 1 in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. (1), 2 for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; orfulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. (1).</IndicationAndUsage>
<Description>KISQALI (ribociclib) is a kinase inhibitor. The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1). Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The molecular formula for ribociclib succinate is C23H30N8O·C4H6O4 and the molecular weight is 552.64 g/mol (Free base: 434.55 g/mol). The chemical structure of ribociclib is shown below. KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0078-0916-61</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14) </PackageDescription>
<NDC11Code>00078-0916-61</NDC11Code>
<ProductNDC>0078-0916</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kisqali Femara Co-pack</ProprietaryName>
<NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170504</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209935</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170504</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. (1), 2 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).</IndicationAndUsage>
<Description>KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1). The molecular formula for ribociclib succinate is C23H30N8O.C4H6O4 and the molecular weight is 552.64 g/mol [Free base: 434.55 g/mol]. The chemical structure of ribociclib is shown below. KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0178-0460-04</NDCCode>
<PackageDescription>10 TUBE in 1 CARTON (0178-0460-04) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>00178-0460-04</NDC11Code>
<ProductNDC>0178-0460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avar-e Green</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, chromium oxide green, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>0178-0465-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0178-0465-02) / 57 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00178-0465-02</NDC11Code>
<ProductNDC>0178-0465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avar-e Ls</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>0178-0465-04</NDCCode>
<PackageDescription>10 TUBE in 1 CARTON (0178-0465-04) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>00178-0465-04</NDC11Code>
<ProductNDC>0178-0465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avar-e Ls</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>0178-0495-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0178-0495-02) / 57 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00178-0495-02</NDC11Code>
<ProductNDC>0178-0495</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ovaceplus</ProprietaryName>
<ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>0178-0495-04</NDCCode>
<PackageDescription>10 TUBE in 1 CARTON (0178-0495-04) / 4 g in 1 TUBE</PackageDescription>
<NDC11Code>00178-0495-04</NDC11Code>
<ProductNDC>0178-0495</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ovaceplus</ProprietaryName>
<ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
<Description>Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>21695-254-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (21695-254-90)</PackageDescription>
<NDC11Code>21695-0254-90</NDC11Code>
<ProductNDC>21695-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077712</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets, USP are opioid analgesics. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid. In addition, the 15 mg and 30 mg tablets contain FD&C Blue #1 aluminum lake, and the 15 mg tablets also contain D&C Yellow #10 aluminum lake. The 5 mg, 15 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>42192-129-16</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (42192-129-16) </PackageDescription>
<NDC11Code>42192-0129-16</NDC11Code>
<ProductNDC>42192-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
<Description>Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Each mL of Sodium Sulfacetamide 10% Wash contains 100 mg of sodium sulfacetamide, USP in a formulation containing cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glyerides, PEG-60 almond triglyceride, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate and sodium thiosulfate. Sodium Sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
</NDC>
<NDC>
<NDCCode>42192-147-08</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (42192-147-08) </PackageDescription>
<NDC11Code>42192-0147-08</NDC11Code>
<ProductNDC>42192-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide 10 Sulfur 2 Cleanser</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium And Sulfur</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140814</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
<Description>Each gram of SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of sulfur in a base containing: BHT, cetyl alcohol, disodium edta, glyceryl stearate, lactic acid, magnesium aluminum silicate, methylparaben, PEG-100 stearate, petrolatum, propylparaben, purified water, sodium C14-16 olefin sulfonate, sodium thiosulfate, stearyl alcohol, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:.</Description>
</NDC>
</NDCList>