{
"NDC": [
{
"NDCCode": "72784-341-97",
"PackageDescription": "4 POUCH in 1 BOX (72784-341-97) > 1 PATCH in 1 POUCH",
"NDC11Code": "72784-0341-97",
"ProductNDC": "72784-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saint External Pain Relieving Bandage",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181015",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Saint Medecine, Inc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181015",
"SamplePackage": "N"
},
{
"NDCCode": "68084-341-97",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68084-341-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-341-96)",
"NDC11Code": "68084-0341-97",
"ProductNDC": "68084-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076933",
"LabelerName": "American Health Packaging",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "81219-341-97",
"PackageDescription": "1041000 mL in 1 TANK (81219-341-97) ",
"NDC11Code": "81219-0341-97",
"ProductNDC": "81219-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201208",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Anthiso Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "265.2",
"StrengthUnit": "mL/354.8mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201208",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer that reduces bacteria on the skin including bacteria that may cause disease. Intended for repeated use."
},
{
"NDCCode": "21695-341-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (21695-341-21)",
"NDC11Code": "21695-0341-21",
"ProductNDC": "21695-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "21695-341-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-341-30)",
"NDC11Code": "21695-0341-30",
"ProductNDC": "21695-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "21695-341-42",
"PackageDescription": "42 CAPSULE in 1 BOTTLE (21695-341-42)",
"NDC11Code": "21695-0341-42",
"ProductNDC": "21695-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "21695-341-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (21695-341-60)",
"NDC11Code": "21695-0341-60",
"ProductNDC": "21695-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "72784-001-01",
"PackageDescription": "480 mL in 1 BOTTLE, PUMP (72784-001-01) ",
"NDC11Code": "72784-0001-01",
"ProductNDC": "72784-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Saint Medicine Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "72784-101-01",
"PackageDescription": "90 VIAL in 1 BOX (72784-101-01) / 5 mL in 1 VIAL",
"NDC11Code": "72784-0101-01",
"ProductNDC": "72784-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saint",
"NonProprietaryName": "Cough Spray",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Saint Medicine, Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3.2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230720",
"SamplePackage": "N"
},
{
"NDCCode": "72784-340-01",
"PackageDescription": "1 POUCH in 1 BOX (72784-340-01) > 1 PATCH in 1 POUCH",
"NDC11Code": "72784-0340-01",
"ProductNDC": "72784-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saint External Pain Relieving Bandage",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190429",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Saint Medicine, Inc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "900",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190429",
"SamplePackage": "N"
},
{
"NDCCode": "72784-342-98",
"PackageDescription": "1 PATCH in 1 BAG (72784-342-98) ",
"NDC11Code": "72784-0342-98",
"ProductNDC": "72784-342",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saint External Pain Relieving Bandage",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Saint Medecine, Inc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N"
},
{
"NDCCode": "72784-343-01",
"PackageDescription": "1 POUCH in 1 BOX (72784-343-01) > 1 PATCH in 1 POUCH",
"NDC11Code": "72784-0343-01",
"ProductNDC": "72784-343",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saint External Pain Relieving Bandage",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190429",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Saint Medicine, Inc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190429",
"SamplePackage": "N"
},
{
"NDCCode": "72784-344-01",
"PackageDescription": "1 POUCH in 1 BOX (72784-344-01) > 1 PATCH in 1 POUCH",
"NDC11Code": "72784-0344-01",
"ProductNDC": "72784-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Saint External Pain Relieving Bandage",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190429",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Saint Medicine, Inc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190429",
"SamplePackage": "N"
},
{
"NDCCode": "72784-351-91",
"PackageDescription": "480 mL in 1 BOTTLE, PUMP (72784-351-91) ",
"NDC11Code": "72784-0351-91",
"ProductNDC": "72784-351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Saint Medicine Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N"
},
{
"NDCCode": "0003-3622-12",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12) ",
"NDC11Code": "00003-3622-12",
"ProductNDC": "0003-3622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reyataz",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030624",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021567",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030624",
"SamplePackage": "N",
"IndicationAndUsage": "REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
"Description": "The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor."
},
{
"NDCCode": "0003-3631-12",
"PackageDescription": "60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12) ",
"NDC11Code": "00003-3631-12",
"ProductNDC": "0003-3631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reyataz",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030624",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021567",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030624",
"SamplePackage": "N",
"IndicationAndUsage": "REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
"Description": "The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor."
},
{
"NDCCode": "0003-3638-10",
"PackageDescription": "30 PACKET in 1 CARTON (0003-3638-10) / 1 POWDER in 1 PACKET",
"NDC11Code": "00003-3638-10",
"ProductNDC": "0003-3638",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reyataz",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206352",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141219",
"SamplePackage": "N",
"IndicationAndUsage": "REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
"Description": "The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor."
},
{
"NDCCode": "0093-5526-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0093-5526-06) ",
"NDC11Code": "00093-5526-06",
"ProductNDC": "0093-5526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atazanavir Sulfate",
"NonProprietaryName": "Atazanavir Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091673",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171227",
"SamplePackage": "N",
"IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol."
},
{
"NDCCode": "0093-5527-06",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0093-5527-06) ",
"NDC11Code": "00093-5527-06",
"ProductNDC": "0093-5527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atazanavir Sulfate",
"NonProprietaryName": "Atazanavir Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091673",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171227",
"SamplePackage": "N",
"IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol."
},
{
"NDCCode": "0093-5528-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-5528-56) ",
"NDC11Code": "00093-5528-56",
"ProductNDC": "0093-5528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atazanavir Sulfate",
"NonProprietaryName": "Atazanavir Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091673",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171227",
"SamplePackage": "N",
"IndicationAndUsage": "Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol."
},
{
"NDCCode": "10596-341-22",
"PackageDescription": "63 g in 1 CONTAINER (10596-341-22)",
"NDC11Code": "10596-0341-22",
"ProductNDC": "10596-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ban",
"ProprietaryNameSuffix": "Clear Antiperspirant Deodorant Cool Sport",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111229",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Kao Brands Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "10.08",
"StrengthUnit": "g/63g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "10695-341-14",
"PackageDescription": ".1 kg in 1 CONTAINER (10695-341-14) ",
"NDC11Code": "10695-0341-14",
"ProductNDC": "10695-341",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydroxocobalamin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260909",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Willow Birch Pharma, LLC.",
"SubstanceName": "HYDROXOCOBALAMIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-09-10",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "09-SEP-26"
},
{
"NDCCode": "10702-341-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (10702-341-01) ",
"NDC11Code": "10702-0341-01",
"ProductNDC": "10702-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apadaz",
"NonProprietaryName": "Benzhydrocodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208653",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE",
"StrengthNumber": "325; 6.12",
"StrengthUnit": "mg/1; mg/1",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190628",
"SamplePackage": "N",
"IndicationAndUsage": "APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1)], reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "APADAZ (benzhydrocodone and acetaminophen) tablet is an immediate-release, fixed-dose combination of an opioid agonist and acetaminophen. APADAZ tablets are white to off-white, capsule shaped tablets that contain 4.08 mg, 6.12 mg, or 8.16 mg of benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen for oral administration. Benzhydrocodone hydrochloride is a prodrug of hydrocodone. It occurs as a fine white powder and is not affected by light. The chemical name is 6,7-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6-yl benzoate hydrochloride. The molecular formula is C 25H 26ClNO 4, which corresponds to a molecular weight of 439.93 g/mol. It has the following chemical structure:. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. The molecular formula for acetaminophen is C 8H 9NO 2, which corresponds to a molecular weight of 151.16 g/mol. It has the following structural formula:. APADAZ tablets contain 4.08 mg, 6.12 mg, or 8.16 mg of benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen and are white to off-white in color. In addition, each tablet contains the following inactive ingredients: crospovidone, microcrystalline cellulose, pregelatinized starch, Povidone K30, and stearic acid."
},
{
"NDCCode": "10812-341-01",
"PackageDescription": "3.4 g in 1 TUBE (10812-341-01) ",
"NDC11Code": "10812-0341-01",
"ProductNDC": "10812-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Moistureshine Spf20",
"ProprietaryNameSuffix": "Mauve On 300",
"NonProprietaryName": "Octinoxate, Octisalate, And Titanium Dioxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100215",
"EndMarketingDate": "20231201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "50; 25; 11",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100215",
"EndMarketingDatePackage": "20231201",
"SamplePackage": "N"
},
{
"NDCCode": "11673-341-16",
"PackageDescription": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11673-341-16) ",
"NDC11Code": "11673-0341-16",
"ProductNDC": "11673-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Laxative",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "TARGET Corporation",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity) . generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "12546-341-30",
"PackageDescription": "30 LOZENGE in 1 BAG (12546-341-30) ",
"NDC11Code": "12546-0341-30",
"ProductNDC": "12546-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Halls",
"ProprietaryNameSuffix": "Extra Strong Menthol Menthol",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Mondelez Global LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N",
"IndicationAndUsage": "<temporarily relieves occasional minor irritation and pain associated with:>. -sore throat. -sore mouth."
},
{
"NDCCode": "13537-341-01",
"PackageDescription": "300 mL in 1 BOTTLE (13537-341-01)",
"NDC11Code": "13537-0341-01",
"ProductNDC": "13537-341",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Men Effective Control",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": ".0036",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps stop irritation and flaking associated with dandruff:."
},
{
"NDCCode": "13668-341-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-01) ",
"NDC11Code": "13668-0341-01",
"ProductNDC": "13668-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203370",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131223",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).",
"Description": "Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3."
},
{
"NDCCode": "13668-341-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-05) ",
"NDC11Code": "13668-0341-05",
"ProductNDC": "13668-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203370",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131223",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).",
"Description": "Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3."
},
{
"NDCCode": "13668-341-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-30) ",
"NDC11Code": "13668-0341-30",
"ProductNDC": "13668-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203370",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131223",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).",
"Description": "Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72784-341-97</NDCCode>
<PackageDescription>4 POUCH in 1 BOX (72784-341-97) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>72784-0341-97</NDC11Code>
<ProductNDC>72784-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saint External Pain Relieving Bandage</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Saint Medecine, Inc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68084-341-97</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68084-341-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-341-96)</PackageDescription>
<NDC11Code>68084-0341-97</NDC11Code>
<ProductNDC>68084-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076933</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>81219-341-97</NDCCode>
<PackageDescription>1041000 mL in 1 TANK (81219-341-97) </PackageDescription>
<NDC11Code>81219-0341-97</NDC11Code>
<ProductNDC>81219-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Anthiso Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>265.2</StrengthNumber>
<StrengthUnit>mL/354.8mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer that reduces bacteria on the skin including bacteria that may cause disease. Intended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-341-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (21695-341-21)</PackageDescription>
<NDC11Code>21695-0341-21</NDC11Code>
<ProductNDC>21695-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>21695-341-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-341-30)</PackageDescription>
<NDC11Code>21695-0341-30</NDC11Code>
<ProductNDC>21695-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>21695-341-42</NDCCode>
<PackageDescription>42 CAPSULE in 1 BOTTLE (21695-341-42)</PackageDescription>
<NDC11Code>21695-0341-42</NDC11Code>
<ProductNDC>21695-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>21695-341-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (21695-341-60)</PackageDescription>
<NDC11Code>21695-0341-60</NDC11Code>
<ProductNDC>21695-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>72784-001-01</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE, PUMP (72784-001-01) </PackageDescription>
<NDC11Code>72784-0001-01</NDC11Code>
<ProductNDC>72784-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Saint Medicine Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72784-101-01</NDCCode>
<PackageDescription>90 VIAL in 1 BOX (72784-101-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>72784-0101-01</NDC11Code>
<ProductNDC>72784-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saint</ProprietaryName>
<NonProprietaryName>Cough Spray</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20230720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Saint Medicine, Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3.2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72784-340-01</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (72784-340-01) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>72784-0340-01</NDC11Code>
<ProductNDC>72784-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saint External Pain Relieving Bandage</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Saint Medicine, Inc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72784-342-98</NDCCode>
<PackageDescription>1 PATCH in 1 BAG (72784-342-98) </PackageDescription>
<NDC11Code>72784-0342-98</NDC11Code>
<ProductNDC>72784-342</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saint External Pain Relieving Bandage</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Saint Medecine, Inc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72784-343-01</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (72784-343-01) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>72784-0343-01</NDC11Code>
<ProductNDC>72784-343</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saint External Pain Relieving Bandage</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Saint Medicine, Inc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72784-344-01</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (72784-344-01) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>72784-0344-01</NDC11Code>
<ProductNDC>72784-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Saint External Pain Relieving Bandage</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Saint Medicine, Inc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72784-351-91</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE, PUMP (72784-351-91) </PackageDescription>
<NDC11Code>72784-0351-91</NDC11Code>
<ProductNDC>72784-351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Saint Medicine Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0003-3622-12</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12) </PackageDescription>
<NDC11Code>00003-3622-12</NDC11Code>
<ProductNDC>0003-3622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reyataz</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030624</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021567</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.</Description>
</NDC>
<NDC>
<NDCCode>0003-3631-12</NDCCode>
<PackageDescription>60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12) </PackageDescription>
<NDC11Code>00003-3631-12</NDC11Code>
<ProductNDC>0003-3631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reyataz</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030624</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021567</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.</Description>
</NDC>
<NDC>
<NDCCode>0003-3638-10</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (0003-3638-10) / 1 POWDER in 1 PACKET</PackageDescription>
<NDC11Code>00003-3638-10</NDC11Code>
<ProductNDC>0003-3638</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reyataz</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206352</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.</Description>
</NDC>
<NDC>
<NDCCode>0093-5526-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0093-5526-06) </PackageDescription>
<NDC11Code>00093-5526-06</NDC11Code>
<ProductNDC>0093-5526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atazanavir Sulfate</ProprietaryName>
<NonProprietaryName>Atazanavir Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091673</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0093-5527-06</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0093-5527-06) </PackageDescription>
<NDC11Code>00093-5527-06</NDC11Code>
<ProductNDC>0093-5527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atazanavir Sulfate</ProprietaryName>
<NonProprietaryName>Atazanavir Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091673</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0093-5528-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-5528-56) </PackageDescription>
<NDC11Code>00093-5528-56</NDC11Code>
<ProductNDC>0093-5528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atazanavir Sulfate</ProprietaryName>
<NonProprietaryName>Atazanavir Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091673</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>10596-341-22</NDCCode>
<PackageDescription>63 g in 1 CONTAINER (10596-341-22)</PackageDescription>
<NDC11Code>10596-0341-22</NDC11Code>
<ProductNDC>10596-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ban</ProprietaryName>
<ProprietaryNameSuffix>Clear Antiperspirant Deodorant Cool Sport</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111229</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Kao Brands Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>10.08</StrengthNumber>
<StrengthUnit>g/63g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>10695-341-14</NDCCode>
<PackageDescription>.1 kg in 1 CONTAINER (10695-341-14) </PackageDescription>
<NDC11Code>10695-0341-14</NDC11Code>
<ProductNDC>10695-341</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydroxocobalamin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260909</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, LLC.</LabelerName>
<SubstanceName>HYDROXOCOBALAMIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-09-10</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-SEP-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>10702-341-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (10702-341-01) </PackageDescription>
<NDC11Code>10702-0341-01</NDC11Code>
<ProductNDC>10702-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apadaz</ProprietaryName>
<NonProprietaryName>Benzhydrocodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208653</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 6.12</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1)], reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>APADAZ (benzhydrocodone and acetaminophen) tablet is an immediate-release, fixed-dose combination of an opioid agonist and acetaminophen. APADAZ tablets are white to off-white, capsule shaped tablets that contain 4.08 mg, 6.12 mg, or 8.16 mg of benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen for oral administration. Benzhydrocodone hydrochloride is a prodrug of hydrocodone. It occurs as a fine white powder and is not affected by light. The chemical name is 6,7-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6-yl benzoate hydrochloride. The molecular formula is C 25H 26ClNO 4, which corresponds to a molecular weight of 439.93 g/mol. It has the following chemical structure:. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. The molecular formula for acetaminophen is C 8H 9NO 2, which corresponds to a molecular weight of 151.16 g/mol. It has the following structural formula:. APADAZ tablets contain 4.08 mg, 6.12 mg, or 8.16 mg of benzhydrocodone (equivalent to 4.45 mg, 6.67 mg, 8.90 mg benzhydrocodone hydrochloride, respectively) and 325 mg of acetaminophen and are white to off-white in color. In addition, each tablet contains the following inactive ingredients: crospovidone, microcrystalline cellulose, pregelatinized starch, Povidone K30, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>10812-341-01</NDCCode>
<PackageDescription>3.4 g in 1 TUBE (10812-341-01) </PackageDescription>
<NDC11Code>10812-0341-01</NDC11Code>
<ProductNDC>10812-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Moistureshine Spf20</ProprietaryName>
<ProprietaryNameSuffix>Mauve On 300</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<EndMarketingDate>20231201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>50; 25; 11</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100215</StartMarketingDatePackage>
<EndMarketingDatePackage>20231201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-341-16</NDCCode>
<PackageDescription>160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11673-341-16) </PackageDescription>
<NDC11Code>11673-0341-16</NDC11Code>
<ProductNDC>11673-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Laxative</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity) . generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12546-341-30</NDCCode>
<PackageDescription>30 LOZENGE in 1 BAG (12546-341-30) </PackageDescription>
<NDC11Code>12546-0341-30</NDC11Code>
<ProductNDC>12546-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Halls</ProprietaryName>
<ProprietaryNameSuffix>Extra Strong Menthol Menthol</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Mondelez Global LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage><temporarily relieves occasional minor irritation and pain associated with:>. -sore throat. -sore mouth.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-341-01</NDCCode>
<PackageDescription>300 mL in 1 BOTTLE (13537-341-01)</PackageDescription>
<NDC11Code>13537-0341-01</NDC11Code>
<ProductNDC>13537-341</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Men Effective Control</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>.0036</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps stop irritation and flaking associated with dandruff:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-341-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-01) </PackageDescription>
<NDC11Code>13668-0341-01</NDC11Code>
<ProductNDC>13668-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203370</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).</IndicationAndUsage>
<Description>Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>13668-341-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-05) </PackageDescription>
<NDC11Code>13668-0341-05</NDC11Code>
<ProductNDC>13668-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203370</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).</IndicationAndUsage>
<Description>Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>13668-341-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-341-30) </PackageDescription>
<NDC11Code>13668-0341-30</NDC11Code>
<ProductNDC>13668-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203370</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2).</IndicationAndUsage>
<Description>Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3.</Description>
</NDC>
</NDCList>