{
"NDC": [
{
"NDCCode": "73750-369-04",
"PackageDescription": "240 mL in 1 BOTTLE (73750-369-04) ",
"NDC11Code": "73750-0369-04",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "73750-369-01",
"PackageDescription": "60 mL in 1 BOTTLE (73750-369-01) ",
"NDC11Code": "73750-0369-01",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "73750-369-02",
"PackageDescription": "100 mL in 1 BOTTLE (73750-369-02) ",
"NDC11Code": "73750-0369-02",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "73750-369-03",
"PackageDescription": "120 mL in 1 BOTTLE (73750-369-03) ",
"NDC11Code": "73750-0369-03",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "73750-369-05",
"PackageDescription": "300 mL in 1 BOTTLE (73750-369-05) ",
"NDC11Code": "73750-0369-05",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "73750-369-06",
"PackageDescription": "500 mL in 1 BOTTLE (73750-369-06) ",
"NDC11Code": "73750-0369-06",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "73750-369-07",
"PackageDescription": "1000 mL in 1 BOTTLE (73750-369-07) ",
"NDC11Code": "73750-0369-07",
"ProductNDC": "73750-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"NonProprietaryName": "Dr Js Natural Advanced Formula Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use."
},
{
"NDCCode": "52183-369-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (52183-369-04) > 118 mL in 1 BOTTLE",
"NDC11Code": "52183-0369-04",
"ProductNDC": "52183-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pediacare Longacting Cough",
"NonProprietaryName": "Dextromethorphan Hbr",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20091029",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Blacksmith Brands, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58177-369-04",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-369-04)",
"NDC11Code": "58177-0369-04",
"ProductNDC": "58177-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077176",
"LabelerName": "Ethex Corporation",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "47.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. The USP dissolution test is pending."
},
{
"NDCCode": "63868-369-04",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (63868-369-04) / 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "63868-0369-04",
"ProductNDC": "63868-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triacting Daytime Cold Cough",
"ProprietaryNameSuffix": "Childrens",
"NonProprietaryName": "Dextromethorphan Hbr, Phenylephrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20140530",
"EndMarketingDate": "20240530",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "QUALITY CHOICE (Chain Drug Marketing Association)",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "5; 2.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140530",
"EndMarketingDatePackage": "20240530",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold."
},
{
"NDCCode": "70157-369-04",
"PackageDescription": "1 CUP in 1 CARTON (70157-369-04) / 50 mL in 1 CUP (70157-369-03) ",
"NDC11Code": "70157-0369-04",
"ProductNDC": "70157-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunceutical Spf 50 Mineral Face Cream",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250121",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Baxter Laboratories Pty. Ltd.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250121",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "84525-369-04",
"PackageDescription": "50 g in 1 BOX (84525-369-04) ",
"NDC11Code": "84525-0369-04",
"ProductNDC": "84525-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colagen Sakura Body Cream",
"NonProprietaryName": "Colagen Sakura Body Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250110",
"EndMarketingDate": "20310110",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250110",
"EndMarketingDatePackage": "20310110",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-369-04",
"PackageDescription": "50 mL in 1 BOTTLE (84756-369-04) ",
"NDC11Code": "84756-0369-04",
"ProductNDC": "84756-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Jojoba Oil",
"NonProprietaryName": "Pure Jojoba Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241120",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"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": "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": "16714-185-02",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (16714-185-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-185-01) ",
"NDC11Code": "16714-0185-02",
"ProductNDC": "16714-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210465",
"LabelerName": "NorthStar Rx LLC",
"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": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211210",
"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": "16714-186-02",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (16714-186-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-186-01) ",
"NDC11Code": "16714-0186-02",
"ProductNDC": "16714-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211210",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210465",
"LabelerName": "NorthStar Rx LLC",
"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": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211210",
"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": "16729-369-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-369-10) ",
"NDC11Code": "16729-0369-10",
"ProductNDC": "16729-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209167",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190327",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped, biconvex, film coated tablets in different sizes and different shades of yellow for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sorbitan monostearate, magnesium stearate, hypromellose, iron oxide red (in 2.5 mg tablets only), iron oxide yellow, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "16729-369-16",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16) ",
"NDC11Code": "16729-0369-16",
"ProductNDC": "16729-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209167",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200505",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped, biconvex, film coated tablets in different sizes and different shades of yellow for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sorbitan monostearate, magnesium stearate, hypromellose, iron oxide red (in 2.5 mg tablets only), iron oxide yellow, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "31722-369-32",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (31722-369-32) / 10 mL in 1 VIAL, MULTI-DOSE (31722-369-10) ",
"NDC11Code": "31722-0369-32",
"ProductNDC": "31722-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218746",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250227",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/mL) for intravenous or intramuscular injection as a sterile solution. Each mL contains bumetanide USP 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 to 7.8 with sodium hydroxide. Chemically, bumetanide USP is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a white crystalline powder having a molecular weight of 364.42, soluble in alkaline solutions, acetone, methanol and ethanol (96%), slightly soluble in chloroform and very slightly soluble in water and hexane, and the following structural formula."
},
{
"NDCCode": "41250-369-16",
"PackageDescription": "1 TUBE in 1 CARTON (41250-369-16) / 56 g in 1 TUBE",
"NDC11Code": "41250-0369-16",
"ProductNDC": "41250-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Itch",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181220",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210107",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:. eczema . psoriasis . poison ivy, oak, sumac . insect bites . detergents . jewelry . cosmetics . soaps . seborrheic dermatitis . temporarily relieves external anal and genital itching . other uses of this product should only be under the advice and supervision of a doctor."
},
{
"NDCCode": "43547-369-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-369-03) ",
"NDC11Code": "43547-0369-03",
"ProductNDC": "43547-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204821",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "43547-369-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (43547-369-09) ",
"NDC11Code": "43547-0369-09",
"ProductNDC": "43547-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204821",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "43547-369-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43547-369-11) ",
"NDC11Code": "43547-0369-11",
"ProductNDC": "43547-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204821",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "43547-369-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (43547-369-50) ",
"NDC11Code": "43547-0369-50",
"ProductNDC": "43547-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204821",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150831",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "43598-560-78",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (43598-560-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-560-79) ",
"NDC11Code": "43598-0560-78",
"ProductNDC": "43598-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210465",
"LabelerName": "Dr.Reddys Laboratories 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": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210201",
"EndMarketingDatePackage": "20250930",
"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": "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": "Deprecated",
"LastUpdate": "2026-10-01",
"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": "47781-369-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (47781-369-01) ",
"NDC11Code": "47781-0369-01",
"ProductNDC": "47781-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020198",
"LabelerName": "Alvogen Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130611",
"EndMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "50563-369-01",
"PackageDescription": "100 SOLUTION in 1 PACKET (50563-369-01) ",
"NDC11Code": "50563-0369-01",
"ProductNDC": "50563-369",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Body Prescriptions Antibacterial Hand Wipes Cranberry Scented",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "3.6",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "■ To decrease bacteria on hands."
},
{
"NDCCode": "51407-369-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (51407-369-05) ",
"NDC11Code": "51407-0369-05",
"ProductNDC": "51407-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibu",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011114",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210222",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>73750-369-04</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE (73750-369-04) </PackageDescription>
<NDC11Code>73750-0369-04</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-369-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (73750-369-01) </PackageDescription>
<NDC11Code>73750-0369-01</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-369-02</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (73750-369-02) </PackageDescription>
<NDC11Code>73750-0369-02</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-369-03</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (73750-369-03) </PackageDescription>
<NDC11Code>73750-0369-03</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-369-05</NDCCode>
<PackageDescription>300 mL in 1 BOTTLE (73750-369-05) </PackageDescription>
<NDC11Code>73750-0369-05</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-369-06</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (73750-369-06) </PackageDescription>
<NDC11Code>73750-0369-06</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-369-07</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (73750-369-07) </PackageDescription>
<NDC11Code>73750-0369-07</NDC11Code>
<ProductNDC>73750-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Dr Js Natural Advanced Formula Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>● Hand Sanitizer to help decrease bacteria on the skin that could cause disease. ● Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52183-369-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52183-369-04) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52183-0369-04</NDC11Code>
<ProductNDC>52183-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pediacare Longacting Cough</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091029</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Blacksmith Brands, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58177-369-04</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-369-04)</PackageDescription>
<NDC11Code>58177-0369-04</NDC11Code>
<ProductNDC>58177-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077176</ApplicationNumber>
<LabelerName>Ethex Corporation</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>47.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once daily oral administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: calcium stearate, carboxymethylcellulose sodium, carnauba wax, croscarmellose sodium, glyceryl behenate, hydrogenated vegetable oil, hypromellose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium stearyl fumarate, titanium dioxide, triacetin, triethyl citrate, vinyl acetate copolymer. The USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>63868-369-04</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (63868-369-04) / 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>63868-0369-04</NDC11Code>
<ProductNDC>63868-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triacting Daytime Cold Cough</ProprietaryName>
<ProprietaryNameSuffix>Childrens</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140530</StartMarketingDate>
<EndMarketingDate>20240530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain Drug Marketing Association)</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 2.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140530</StartMarketingDatePackage>
<EndMarketingDatePackage>20240530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70157-369-04</NDCCode>
<PackageDescription>1 CUP in 1 CARTON (70157-369-04) / 50 mL in 1 CUP (70157-369-03) </PackageDescription>
<NDC11Code>70157-0369-04</NDC11Code>
<ProductNDC>70157-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunceutical Spf 50 Mineral Face Cream</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Baxter Laboratories Pty. Ltd.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84525-369-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84525-369-04) </PackageDescription>
<NDC11Code>84525-0369-04</NDC11Code>
<ProductNDC>84525-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colagen Sakura Body Cream</ProprietaryName>
<NonProprietaryName>Colagen Sakura Body Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250110</StartMarketingDate>
<EndMarketingDate>20310110</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250110</StartMarketingDatePackage>
<EndMarketingDatePackage>20310110</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-369-04</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (84756-369-04) </PackageDescription>
<NDC11Code>84756-0369-04</NDC11Code>
<ProductNDC>84756-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Jojoba Oil</ProprietaryName>
<NonProprietaryName>Pure Jojoba Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</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>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>16714-185-02</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (16714-185-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-185-01) </PackageDescription>
<NDC11Code>16714-0185-02</NDC11Code>
<ProductNDC>16714-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210465</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</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>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211210</StartMarketingDatePackage>
<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>16714-186-02</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (16714-186-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-186-01) </PackageDescription>
<NDC11Code>16714-0186-02</NDC11Code>
<ProductNDC>16714-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211210</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210465</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</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>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211210</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>16729-369-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-369-10) </PackageDescription>
<NDC11Code>16729-0369-10</NDC11Code>
<ProductNDC>16729-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209167</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped, biconvex, film coated tablets in different sizes and different shades of yellow for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sorbitan monostearate, magnesium stearate, hypromellose, iron oxide red (in 2.5 mg tablets only), iron oxide yellow, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>16729-369-16</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16) </PackageDescription>
<NDC11Code>16729-0369-16</NDC11Code>
<ProductNDC>16729-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209167</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped, biconvex, film coated tablets in different sizes and different shades of yellow for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sorbitan monostearate, magnesium stearate, hypromellose, iron oxide red (in 2.5 mg tablets only), iron oxide yellow, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>31722-369-32</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (31722-369-32) / 10 mL in 1 VIAL, MULTI-DOSE (31722-369-10) </PackageDescription>
<NDC11Code>31722-0369-32</NDC11Code>
<ProductNDC>31722-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218746</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/mL) for intravenous or intramuscular injection as a sterile solution. Each mL contains bumetanide USP 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 to 7.8 with sodium hydroxide. Chemically, bumetanide USP is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a white crystalline powder having a molecular weight of 364.42, soluble in alkaline solutions, acetone, methanol and ethanol (96%), slightly soluble in chloroform and very slightly soluble in water and hexane, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>41250-369-16</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (41250-369-16) / 56 g in 1 TUBE</PackageDescription>
<NDC11Code>41250-0369-16</NDC11Code>
<ProductNDC>41250-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Itch</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181220</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210107</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:. eczema . psoriasis . poison ivy, oak, sumac . insect bites . detergents . jewelry . cosmetics . soaps . seborrheic dermatitis . temporarily relieves external anal and genital itching . other uses of this product should only be under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-369-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-369-03) </PackageDescription>
<NDC11Code>43547-0369-03</NDC11Code>
<ProductNDC>43547-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204821</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-369-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43547-369-09) </PackageDescription>
<NDC11Code>43547-0369-09</NDC11Code>
<ProductNDC>43547-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204821</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-369-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43547-369-11) </PackageDescription>
<NDC11Code>43547-0369-11</NDC11Code>
<ProductNDC>43547-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204821</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-369-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43547-369-50) </PackageDescription>
<NDC11Code>43547-0369-50</NDC11Code>
<ProductNDC>43547-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204821</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP, are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, iron oxides yellow, iron oxides red (only 80 mg and 320 mg), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-560-78</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (43598-560-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-560-79) </PackageDescription>
<NDC11Code>43598-0560-78</NDC11Code>
<ProductNDC>43598-560</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>20250930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210465</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories 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>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</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>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>Deprecated</Status>
<LastUpdate>2026-10-01</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>47781-369-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (47781-369-01) </PackageDescription>
<NDC11Code>47781-0369-01</NDC11Code>
<ProductNDC>47781-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20200401</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020198</ApplicationNumber>
<LabelerName>Alvogen Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130611</StartMarketingDatePackage>
<EndMarketingDatePackage>20200401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50563-369-01</NDCCode>
<PackageDescription>100 SOLUTION in 1 PACKET (50563-369-01) </PackageDescription>
<NDC11Code>50563-0369-01</NDC11Code>
<ProductNDC>50563-369</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Body Prescriptions Antibacterial Hand Wipes Cranberry Scented</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>3.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ To decrease bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51407-369-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (51407-369-05) </PackageDescription>
<NDC11Code>51407-0369-05</NDC11Code>
<ProductNDC>51407-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibu</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011114</StartMarketingDate>
<EndMarketingDate>20270831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210222</StartMarketingDatePackage>
<EndMarketingDatePackage>20270831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p- isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
</NDC>
</NDCList>