{
"NDC": [
{
"NDCCode": "83046-369-13",
"PackageDescription": "177 mL in 1 CAN (83046-369-13) ",
"NDC11Code": "83046-0369-13",
"ProductNDC": "83046-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oars And Alps Spf 50 100% Mineral Antioxidant Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Oars and Alps LLC",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "15.7; 3.4",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83046-360-13",
"PackageDescription": "177 mL in 1 CAN (83046-360-13) ",
"NDC11Code": "83046-0360-13",
"ProductNDC": "83046-360",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oars And Alps Spf 50 Hydrating Antioxidant Sunscreenspray",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Oars and Alps LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.9; 9.8; 4.9; 9.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83046-365-13",
"PackageDescription": "177 mL in 1 CAN (83046-365-13) ",
"NDC11Code": "83046-0365-13",
"ProductNDC": "83046-365",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oars And Alps Spf 30 Hydrating Antioxidant Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Oars and Alps LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.4; 9.8; 4.9; 9.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83046-370-13",
"PackageDescription": "177 mL in 1 CAN (83046-370-13) ",
"NDC11Code": "83046-0370-13",
"ProductNDC": "83046-370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oars And Alps Spf 70 Hydrating Antioxidant Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Oars and Alps LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.9; 9.8; 4.9; 9.5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "83046-372-13",
"PackageDescription": "177 mL in 1 CAN (83046-372-13) ",
"NDC11Code": "83046-0372-13",
"ProductNDC": "83046-372",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oars And Alps 100% Mineral Antioxidant Sunscreen",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Oars and Alps LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "15",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220701",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "10356-101-13",
"PackageDescription": "369 g in 1 JAR (10356-101-13)",
"NDC11Code": "10356-0101-13",
"ProductNDC": "10356-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaphor Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19910101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "41",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "20276-815-13",
"PackageDescription": "369 g in 1 JAR (20276-815-13) ",
"NDC11Code": "20276-0815-13",
"ProductNDC": "20276-815",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum Jelly",
"ProprietaryNameSuffix": "Scented",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Delta Brands Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "99.9",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210812",
"SamplePackage": "N",
"IndicationAndUsage": "USES:. My Fair Baby Petroleum Jelly helps treat and prevent diaper rash. : 1 Helps seal out wetness , 2 Temporarily protects and helps relieved chapped or cracked skin and lips, 3 Helps protect from the drying effects of cold and wind."
},
{
"NDCCode": "42669-214-13",
"PackageDescription": "369 g in 1 JAR (42669-214-13) ",
"NDC11Code": "42669-0214-13",
"ProductNDC": "42669-214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum Jelly",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Davion, Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N"
},
{
"NDCCode": "49738-351-13",
"PackageDescription": "369 g in 1 JAR (49738-351-13)",
"NDC11Code": "49738-0351-13",
"ProductNDC": "49738-351",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Little Ones Petroleum",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150427",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "KMART CORPORATION",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Temporarily protects minor: 1 cuts, 2 scrapes, 3 burns, 4 temporarily protects and helps relieve chapped or cracked skin and lips, 5 helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "55681-049-13",
"PackageDescription": "369 g in 1 JAR (55681-049-13) ",
"NDC11Code": "55681-0049-13",
"ProductNDC": "55681-049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Procure Petroleum",
"NonProprietaryName": "100% White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Twin Med LLC",
"SubstanceName": "WHITE PETROLATUM",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects minor: cuts, scrapes, burns. Temporarily protects chafed, chapped or cracked skin. Helps protect against the drying effects of wind and cold weather. Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "62257-369-13",
"PackageDescription": "800 mL in 1 BAG (62257-369-13)",
"NDC11Code": "62257-0369-13",
"ProductNDC": "62257-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean All",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "ABC Compounding Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "0555-9016-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9016-58",
"ProductNDC": "0555-9016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20020926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075804",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020926",
"SamplePackage": "N",
"IndicationAndUsage": "Sprintec® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1).",
"Description": "Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0555-9018-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9018-58",
"ProductNDC": "0555-9018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20031229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075808",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20031229",
"SamplePackage": "N",
"IndicationAndUsage": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).",
"Description": "Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol, USP is designated as (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol). Each active gray tablet contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (which consists of FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake), magnesium stearate, and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each active blue tablet contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white placebo tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "16571-697-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-03) ",
"NDC11Code": "16571-0697-03",
"ProductNDC": "16571-697",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200111",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16571-697-50",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-50) ",
"NDC11Code": "16571-0697-50",
"ProductNDC": "16571-697",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200111",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16571-698-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-01) ",
"NDC11Code": "16571-0698-01",
"ProductNDC": "16571-698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200111",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16571-698-09",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-09) ",
"NDC11Code": "16571-0698-09",
"ProductNDC": "16571-698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200111",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "16571-698-50",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-50) ",
"NDC11Code": "16571-0698-50",
"ProductNDC": "16571-698",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200111",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "21695-369-18",
"PackageDescription": "18 TABLET, FILM COATED in 1 BOTTLE (21695-369-18)",
"NDC11Code": "21695-0369-18",
"ProductNDC": "21695-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zidovudine",
"NonProprietaryName": "Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077267",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ZIDOVUDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ": 1 Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1), 2 Prevention of maternal-fetal HIV-1 transmission. (1.2).",
"Description": "Zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3'-azido-3'-deoxythymidine; it has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg/mL in water at 25°C. The molecular formula is C. 10. H. 13. N. 5. O. 4. . Zidovudine tablets are for oral administration. Each film-coated tablet contains 300 mg of zidovudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "37000-369-45",
"PackageDescription": "45 g in 1 CANISTER (37000-369-45)",
"NDC11Code": "37000-0369-45",
"ProductNDC": "37000-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Outlast Invisible",
"ProprietaryNameSuffix": "Sport Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"EndMarketingDate": "20171011",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": ".19",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "37000-369-73",
"PackageDescription": "73 g in 1 CANISTER (37000-369-73)",
"NDC11Code": "37000-0369-73",
"ProductNDC": "37000-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Outlast Invisible",
"ProprietaryNameSuffix": "Sport Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"EndMarketingDate": "20171011",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": ".19",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "43598-561-78",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (43598-561-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-561-79) ",
"NDC11Code": "43598-0561-78",
"ProductNDC": "43598-561",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210465",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210201",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"Description": "The active ingredient in lansoprazole delayed-release orally disintegrating tablet is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release orally disintegrating tablets for oral administration. Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 and 30 mg of lansoprazole USP per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: aspartame1, citric acid anhydrous powder, crospovidone, ethyl acrylate and methyl methacrylate copolymer dispersion, glyceryl monostearate, hydroxypropyl methyl cellulose 3cps, hydroxypropyl methyl cellulose 15cps, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, iron oxide red, iron oxide yellow, magnesium carbonate, mannitol, magnesium stearate, methylacrylic acid ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium hydroxide, strawberry guarana flavour, sugar spheres, talc, titanium dioxide, and triehtyl citrate. 1 Phenylketonurics: Lansoprazole Delayed-Release Orally Disintegrating Tablets Contain Phenylalanine 2.52 mg per 15 mg Tablet and 5.04 mg per 30 mg Tablet."
},
{
"NDCCode": "47469-240-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (47469-240-02) > 30 mL in 1 BOTTLE, DROPPER (47469-240-01)",
"NDC11Code": "47469-0240-02",
"ProductNDC": "47469-240",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hanskin Bio Origin 369",
"NonProprietaryName": "Sunflower",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Celltrion Skincure Co.,Ltd.",
"SubstanceName": "SUNFLOWER OIL",
"StrengthNumber": "19.13",
"StrengthUnit": "g/30mL",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49035-386-41",
"PackageDescription": ".369 kg in 1 BOTTLE, PLASTIC (49035-386-41) ",
"NDC11Code": "49035-0386-41",
"ProductNDC": "49035-386",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Medicated Body",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19950117",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Wal-Mart Stores, Inc",
"SubstanceName": "DIMETHICONE; MENTHOL",
"StrengthNumber": "5; .5",
"StrengthUnit": "kg/100kg; kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2020-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19950117",
"SamplePackage": "N"
},
{
"NDCCode": "49884-147-11",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-147-11) ",
"NDC11Code": "49884-0147-11",
"ProductNDC": "49884-147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexlansoprazole",
"NonProprietaryName": "Dexlansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202294",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXLANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230610",
"SamplePackage": "N",
"IndicationAndUsage": "Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .",
"Description": "The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)]."
},
{
"NDCCode": "49884-148-09",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09) ",
"NDC11Code": "49884-0148-09",
"ProductNDC": "49884-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexlansoprazole",
"NonProprietaryName": "Dexlansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202294",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXLANSOPRAZOLE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .",
"Description": "The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)]."
},
{
"NDCCode": "49884-148-11",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11) ",
"NDC11Code": "49884-0148-11",
"ProductNDC": "49884-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexlansoprazole",
"NonProprietaryName": "Dexlansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202294",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "DEXLANSOPRAZOLE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .",
"Description": "The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)]."
},
{
"NDCCode": "49967-369-01",
"PackageDescription": "88 mL in 1 TUBE (49967-369-01)",
"NDC11Code": "49967-0369-01",
"ProductNDC": "49967-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loreal Paris Sublime Sun",
"ProprietaryNameSuffix": "Advanced Sunscreen Spf 50 Plus",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2.64; 13.2; 4.4; 4.4; 5.28",
"StrengthUnit": "mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50580-529-01",
"PackageDescription": "1 KIT in 1 PACKAGE (50580-529-01) * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) ",
"NDC11Code": "50580-0529-01",
"ProductNDC": "50580-529",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 3-pack",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20190805",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190805",
"SamplePackage": "N"
},
{
"NDCCode": "51079-121-08",
"PackageDescription": "80 BLISTER PACK in 1 CARTON (51079-121-08) / 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (51079-121-01) ",
"NDC11Code": "51079-0121-08",
"ProductNDC": "51079-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090763",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091201",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults. ( 1.1) , 2 Eradication of H. pylorito reduce the risk of duodenal ulcer recurrence in adults. ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults. ( 1.3) , 4 Treatment of active benign gastric ulcer in adults. ( 1.4) , 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8) , 9 Maintenance of healing of EE in adults. ( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10) .",
"Description": "The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoro-ethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol, polysorbate 80, sucrose, sugar spheres (corn starch and sucrose), talc and titanium dioxide. The 15 mg capsules also contain FD&C Green No. 3 and FD&C Red No. 40. The 30 mg capsules also contain FD&C Blue No. 1 and FD&C Red No 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83046-369-13</NDCCode>
<PackageDescription>177 mL in 1 CAN (83046-369-13) </PackageDescription>
<NDC11Code>83046-0369-13</NDC11Code>
<ProductNDC>83046-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oars And Alps Spf 50 100% Mineral Antioxidant Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Oars and Alps LLC</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>15.7; 3.4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83046-360-13</NDCCode>
<PackageDescription>177 mL in 1 CAN (83046-360-13) </PackageDescription>
<NDC11Code>83046-0360-13</NDC11Code>
<ProductNDC>83046-360</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oars And Alps Spf 50 Hydrating Antioxidant Sunscreenspray</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Oars and Alps LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2.9; 9.8; 4.9; 9.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83046-365-13</NDCCode>
<PackageDescription>177 mL in 1 CAN (83046-365-13) </PackageDescription>
<NDC11Code>83046-0365-13</NDC11Code>
<ProductNDC>83046-365</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oars And Alps Spf 30 Hydrating Antioxidant Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Oars and Alps LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2.4; 9.8; 4.9; 9.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83046-370-13</NDCCode>
<PackageDescription>177 mL in 1 CAN (83046-370-13) </PackageDescription>
<NDC11Code>83046-0370-13</NDC11Code>
<ProductNDC>83046-370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oars And Alps Spf 70 Hydrating Antioxidant Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Oars and Alps LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2.9; 9.8; 4.9; 9.5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83046-372-13</NDCCode>
<PackageDescription>177 mL in 1 CAN (83046-372-13) </PackageDescription>
<NDC11Code>83046-0372-13</NDC11Code>
<ProductNDC>83046-372</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oars And Alps 100% Mineral Antioxidant Sunscreen</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Oars and Alps LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10356-101-13</NDCCode>
<PackageDescription>369 g in 1 JAR (10356-101-13)</PackageDescription>
<NDC11Code>10356-0101-13</NDC11Code>
<ProductNDC>10356-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquaphor Healing</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19910101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>41</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>20276-815-13</NDCCode>
<PackageDescription>369 g in 1 JAR (20276-815-13) </PackageDescription>
<NDC11Code>20276-0815-13</NDC11Code>
<ProductNDC>20276-815</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum Jelly</ProprietaryName>
<ProprietaryNameSuffix>Scented</ProprietaryNameSuffix>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Delta Brands Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>99.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES:. My Fair Baby Petroleum Jelly helps treat and prevent diaper rash. : 1 Helps seal out wetness , 2 Temporarily protects and helps relieved chapped or cracked skin and lips, 3 Helps protect from the drying effects of cold and wind.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42669-214-13</NDCCode>
<PackageDescription>369 g in 1 JAR (42669-214-13) </PackageDescription>
<NDC11Code>42669-0214-13</NDC11Code>
<ProductNDC>42669-214</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum Jelly</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Davion, Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49738-351-13</NDCCode>
<PackageDescription>369 g in 1 JAR (49738-351-13)</PackageDescription>
<NDC11Code>49738-0351-13</NDC11Code>
<ProductNDC>49738-351</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Little Ones Petroleum</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150427</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>KMART CORPORATION</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily protects minor: 1 cuts, 2 scrapes, 3 burns, 4 temporarily protects and helps relieve chapped or cracked skin and lips, 5 helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55681-049-13</NDCCode>
<PackageDescription>369 g in 1 JAR (55681-049-13) </PackageDescription>
<NDC11Code>55681-0049-13</NDC11Code>
<ProductNDC>55681-049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Procure Petroleum</ProprietaryName>
<NonProprietaryName>100% White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Twin Med LLC</LabelerName>
<SubstanceName>WHITE PETROLATUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects minor: cuts, scrapes, burns. Temporarily protects chafed, chapped or cracked skin. Helps protect against the drying effects of wind and cold weather. Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62257-369-13</NDCCode>
<PackageDescription>800 mL in 1 BAG (62257-369-13)</PackageDescription>
<NDC11Code>62257-0369-13</NDC11Code>
<ProductNDC>62257-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean All</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>ABC Compounding Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0555-9016-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9016-58</NDC11Code>
<ProductNDC>0555-9016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075804</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sprintec® is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1).</IndicationAndUsage>
<Description>Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0555-9018-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9018-58</NDC11Code>
<ProductNDC>0555-9018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20031229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075808</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Sprintec® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
<Description>Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol, USP is designated as (19-Nor-17α-pregna,1,3,5(10)-trien-20-yne-3, 17-diol). Each active gray tablet contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (which consists of FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake), magnesium stearate, and pregelatinized corn starch. Each active light blue tablet contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each active blue tablet contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP. Inactive ingredients include anhydrous lactose, FD&C Blue No. 2 Aluminum Lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white placebo tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows. C23H31NO3 M.W. 369.50. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>16571-697-03</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-03) </PackageDescription>
<NDC11Code>16571-0697-03</NDC11Code>
<ProductNDC>16571-697</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-697-50</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-697-50) </PackageDescription>
<NDC11Code>16571-0697-50</NDC11Code>
<ProductNDC>16571-697</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-698-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-01) </PackageDescription>
<NDC11Code>16571-0698-01</NDC11Code>
<ProductNDC>16571-698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-698-09</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-09) </PackageDescription>
<NDC11Code>16571-0698-09</NDC11Code>
<ProductNDC>16571-698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-698-50</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-50) </PackageDescription>
<NDC11Code>16571-0698-50</NDC11Code>
<ProductNDC>16571-698</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules 15 mg and 30 mg is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres (consists of sucrose and corn starch), talc and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 15 mg contains D&C Red 28, FD&C Blue 1, FD&C Green 3, FD&C Red 40, gelatin, purified water and titanium dioxide. The hard gelatin capsule shell for lansoprazole delayed-release capsules 30 mg contains D&C Red 28, FD&C Blue 1, FD&C Red 40, gelatin, purified water and titanium dioxide. The white printing ink contains ammonia, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-369-18</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BOTTLE (21695-369-18)</PackageDescription>
<NDC11Code>21695-0369-18</NDC11Code>
<ProductNDC>21695-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zidovudine</ProprietaryName>
<NonProprietaryName>Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077267</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ZIDOVUDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>: 1 Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1), 2 Prevention of maternal-fetal HIV-1 transmission. (1.2).</IndicationAndUsage>
<Description>Zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3'-azido-3'-deoxythymidine; it has the following structural formula. Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg/mL in water at 25°C. The molecular formula is C. 10. H. 13. N. 5. O. 4. . Zidovudine tablets are for oral administration. Each film-coated tablet contains 300 mg of zidovudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>37000-369-45</NDCCode>
<PackageDescription>45 g in 1 CANISTER (37000-369-45)</PackageDescription>
<NDC11Code>37000-0369-45</NDC11Code>
<ProductNDC>37000-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Outlast Invisible</ProprietaryName>
<ProprietaryNameSuffix>Sport Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<EndMarketingDate>20171011</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>.19</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>37000-369-73</NDCCode>
<PackageDescription>73 g in 1 CANISTER (37000-369-73)</PackageDescription>
<NDC11Code>37000-0369-73</NDC11Code>
<ProductNDC>37000-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Outlast Invisible</ProprietaryName>
<ProprietaryNameSuffix>Sport Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<EndMarketingDate>20171011</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>.19</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>43598-561-78</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (43598-561-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-561-79) </PackageDescription>
<NDC11Code>43598-0561-78</NDC11Code>
<ProductNDC>43598-561</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210465</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in lansoprazole delayed-release orally disintegrating tablet is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole USP is supplied as delayed-release orally disintegrating tablets for oral administration. Lansoprazole delayed-release orally disintegrating tablets are available in two dosage strengths: 15 and 30 mg of lansoprazole USP per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: aspartame1, citric acid anhydrous powder, crospovidone, ethyl acrylate and methyl methacrylate copolymer dispersion, glyceryl monostearate, hydroxypropyl methyl cellulose 3cps, hydroxypropyl methyl cellulose 15cps, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, iron oxide red, iron oxide yellow, magnesium carbonate, mannitol, magnesium stearate, methylacrylic acid ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium hydroxide, strawberry guarana flavour, sugar spheres, talc, titanium dioxide, and triehtyl citrate. 1 Phenylketonurics: Lansoprazole Delayed-Release Orally Disintegrating Tablets Contain Phenylalanine 2.52 mg per 15 mg Tablet and 5.04 mg per 30 mg Tablet.</Description>
</NDC>
<NDC>
<NDCCode>47469-240-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (47469-240-02) > 30 mL in 1 BOTTLE, DROPPER (47469-240-01)</PackageDescription>
<NDC11Code>47469-0240-02</NDC11Code>
<ProductNDC>47469-240</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hanskin Bio Origin 369</ProprietaryName>
<NonProprietaryName>Sunflower</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Celltrion Skincure Co.,Ltd.</LabelerName>
<SubstanceName>SUNFLOWER OIL</SubstanceName>
<StrengthNumber>19.13</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49035-386-41</NDCCode>
<PackageDescription>.369 kg in 1 BOTTLE, PLASTIC (49035-386-41) </PackageDescription>
<NDC11Code>49035-0386-41</NDC11Code>
<ProductNDC>49035-386</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Medicated Body</ProprietaryName>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19950117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc</LabelerName>
<SubstanceName>DIMETHICONE; MENTHOL</SubstanceName>
<StrengthNumber>5; .5</StrengthNumber>
<StrengthUnit>kg/100kg; kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49884-147-11</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-147-11) </PackageDescription>
<NDC11Code>49884-0147-11</NDC11Code>
<ProductNDC>49884-147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexlansoprazole</ProprietaryName>
<NonProprietaryName>Dexlansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202294</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXLANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .</IndicationAndUsage>
<Description>The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)].</Description>
</NDC>
<NDC>
<NDCCode>49884-148-09</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09) </PackageDescription>
<NDC11Code>49884-0148-09</NDC11Code>
<ProductNDC>49884-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexlansoprazole</ProprietaryName>
<NonProprietaryName>Dexlansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202294</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXLANSOPRAZOLE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .</IndicationAndUsage>
<Description>The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)].</Description>
</NDC>
<NDC>
<NDCCode>49884-148-11</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11) </PackageDescription>
<NDC11Code>49884-0148-11</NDC11Code>
<ProductNDC>49884-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexlansoprazole</ProprietaryName>
<NonProprietaryName>Dexlansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202294</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>DEXLANSOPRAZOLE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: 1 Healing of all grades of erosive esophagitis (EE). (1.1) , 2 Maintenance of healed EE and relief of heartburn. (1.2) , 3 Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) .</IndicationAndUsage>
<Description>The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its molecular formula is: C16H14F3N3O2S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure. Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)]. Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate. The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No. 5 (tartrazine) [see Warnings and Precautions (5)].</Description>
</NDC>
<NDC>
<NDCCode>49967-369-01</NDCCode>
<PackageDescription>88 mL in 1 TUBE (49967-369-01)</PackageDescription>
<NDC11Code>49967-0369-01</NDC11Code>
<ProductNDC>49967-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loreal Paris Sublime Sun</ProprietaryName>
<ProprietaryNameSuffix>Advanced Sunscreen Spf 50 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2.64; 13.2; 4.4; 4.4; 5.28</StrengthNumber>
<StrengthUnit>mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50580-529-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (50580-529-01) * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) </PackageDescription>
<NDC11Code>50580-0529-01</NDC11Code>
<ProductNDC>50580-529</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 3-pack</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190805</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-121-08</NDCCode>
<PackageDescription>80 BLISTER PACK in 1 CARTON (51079-121-08) / 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (51079-121-01) </PackageDescription>
<NDC11Code>51079-0121-08</NDC11Code>
<ProductNDC>51079-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090763</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults. ( 1.1) , 2 Eradication of H. pylorito reduce the risk of duodenal ulcer recurrence in adults. ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults. ( 1.3) , 4 Treatment of active benign gastric ulcer in adults. ( 1.4) , 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8) , 9 Maintenance of healing of EE in adults. ( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10) .</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoro-ethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol, polysorbate 80, sucrose, sugar spheres (corn starch and sucrose), talc and titanium dioxide. The 15 mg capsules also contain FD&C Green No. 3 and FD&C Red No. 40. The 30 mg capsules also contain FD&C Blue No. 1 and FD&C Red No 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
</NDCList>