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"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) complies with USP Drug Release Test #2. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period."
},
{
"NDCCode": "22431-525-01",
"PackageDescription": "222 mL in 1 BOTTLE (22431-525-01)",
"NDC11Code": "22431-0525-01",
"ProductNDC": "22431-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kitchen Citrus",
"ProprietaryNameSuffix": "Foaming Hand",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110722",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Blue Cross Laboratories, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".46",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-09-13"
},
{
"NDCCode": "31260-525-01",
"PackageDescription": "136 kg in 1 DRUM (31260-525-01) ",
"NDC11Code": "31260-0525-01",
"ProductNDC": "31260-525",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250722",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Gulbrandsen Technologies India Private Limited",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-27",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "22-JUL-25"
},
{
"NDCCode": "31722-525-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01) ",
"NDC11Code": "31722-0525-01",
"ProductNDC": "31722-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090061",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150613",
"SamplePackage": "N",
"IndicationAndUsage": "Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use:Finasteride tablets are not approved for the prevention of prostate cancer (1.3).",
"Description": "Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize."
},
{
"NDCCode": "42291-525-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-525-01) ",
"NDC11Code": "42291-0525-01",
"ProductNDC": "42291-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078703",
"LabelerName": "AvKARE",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170516",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1."
},
{
"NDCCode": "42806-525-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42806-525-01)",
"NDC11Code": "42806-0525-01",
"ProductNDC": "42806-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076868",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-03-10"
},
{
"NDCCode": "46123-525-01",
"PackageDescription": "334 L in 1 CYLINDER (46123-525-01) ",
"NDC11Code": "46123-0525-01",
"ProductNDC": "46123-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen-carbon Dioxide Mixture",
"NonProprietaryName": "Oxygen-carbon Dioxide Mixture",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19660101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "Roberts Oxygen Company, Inc.",
"SubstanceName": "CARBON DIOXIDE; OXYGEN",
"StrengthNumber": "700; 300",
"StrengthUnit": "mL/L; mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19660101",
"SamplePackage": "N"
},
{
"NDCCode": "49574-525-01",
"PackageDescription": "25 kg in 1 DRUM (49574-525-01) ",
"NDC11Code": "49574-0525-01",
"ProductNDC": "49574-525",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Phosphate, Monobasic, Monohydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20041001",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Hunan Jiudian Pharmaceutical Co.,Ltd.",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-OCT-04"
},
{
"NDCCode": "49967-525-01",
"PackageDescription": "1 TUBE in 1 CARTON (49967-525-01) / 40 mL in 1 TUBE",
"NDC11Code": "49967-0525-01",
"ProductNDC": "49967-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum Spf 50 Sunscreen",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "50580-525-01",
"PackageDescription": "240 mL in 1 BOTTLE, PLASTIC (50580-525-01) ",
"NDC11Code": "50580-0525-01",
"ProductNDC": "50580-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tylenol Cold Max",
"ProprietaryNameSuffix": "Day",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150525",
"SamplePackage": "N"
},
{
"NDCCode": "51079-525-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-525-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-525-01) ",
"NDC11Code": "51079-0525-20",
"ProductNDC": "51079-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070709",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076930",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070709",
"EndMarketingDatePackage": "20190430",
"SamplePackage": "N"
},
{
"NDCCode": "51346-525-02",
"PackageDescription": "100 POUCH in 1 CARTON (51346-525-02) > 2 mL in 1 POUCH (51346-525-01) ",
"NDC11Code": "51346-0525-02",
"ProductNDC": "51346-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand And Nature Sanitizer Ge L Rose",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "1.09",
"StrengthUnit": "g/2mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N"
},
{
"NDCCode": "51407-525-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (51407-525-01) ",
"NDC11Code": "51407-0525-01",
"ProductNDC": "51407-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074569",
"LabelerName": "Golden State Medical Supply Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180320",
"SamplePackage": "N"
},
{
"NDCCode": "52919-021-14",
"PackageDescription": "525 AMPULE in 1 CARTON (52919-021-14) > 2 mL in 1 AMPULE (52919-021-01)",
"NDC11Code": "52919-0021-14",
"ProductNDC": "52919-021",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Polidocanol",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Siegfried Hameln GmbH",
"SubstanceName": "POLIDOCANOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2018-10-18",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "52919-022-14",
"PackageDescription": "525 AMPULE in 1 CARTON (52919-022-14) > 2 mL in 1 AMPULE (52919-022-01)",
"NDC11Code": "52919-0022-14",
"ProductNDC": "52919-022",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Polidocanol",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Siegfried Hameln GmbH",
"SubstanceName": "POLIDOCANOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2020-11-21",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "52919-024-14",
"PackageDescription": "525 AMPULE in 1 CARTON (52919-024-14) / 2 mL in 1 AMPULE (52919-024-01) ",
"NDC11Code": "52919-0024-14",
"ProductNDC": "52919-024",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Polidocanol",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20190614",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Siegfried Hameln GmbH",
"SubstanceName": "POLIDOCANOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-11-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "14-JUN-19"
},
{
"NDCCode": "53208-525-02",
"PackageDescription": "1 CONTAINER in 1 BOX (53208-525-02) > 45 mL in 1 CONTAINER (53208-525-01)",
"NDC11Code": "53208-0525-02",
"ProductNDC": "53208-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The History Of Whoo Gongjinhyang Seol Whitening Sun",
"NonProprietaryName": "Zinc Oxide, Ensulizole, Polysilicone-15, Titanium Dioxide, Atractylodes Japonica Root Oil",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110524",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "LG Household and Healthcare, Inc.",
"SubstanceName": "ZINC OXIDE; ENSULIZOLE; TITANIUM DIOXIDE; ATRACTYLODES JAPONICA ROOT OIL; POLYSILICONE-15",
"StrengthNumber": "6.117; 3.9; 2.48; .05; 3",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54860-525-01",
"PackageDescription": "50 mL in 1 BOTTLE, SPRAY (54860-525-01) ",
"NDC11Code": "54860-0525-01",
"ProductNDC": "54860-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Luxury Hand Sanitizer Cashmere Char",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251019",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251019",
"SamplePackage": "Y",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product."
},
{
"NDCCode": "55111-525-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-525-01) / 100 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0525-01",
"ProductNDC": "55111-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "59137-525-01",
"PackageDescription": "1 PACKAGE in 1 CARTON (59137-525-01) / .35 mL in 1 PACKAGE (59137-525-00) ",
"NDC11Code": "59137-0525-01",
"ProductNDC": "59137-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasuvo",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20140710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205776",
"LabelerName": "Medexus Pharma Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "17.5",
"StrengthUnit": "mg/.35mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
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<PackageDescription>88 mL in 1 TUBE (10812-525-01)</PackageDescription>
<NDC11Code>10812-0525-01</NDC11Code>
<ProductNDC>10812-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Wet Skin Swim Humidity Sweat</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Sfp45 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 40; 50; 40; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13537-525-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-525-02) > 4 g in 1 TUBE (13537-525-01)</PackageDescription>
<NDC11Code>13537-0525-02</NDC11Code>
<ProductNDC>13537-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Hydratess</ProprietaryName>
<ProprietaryNameSuffix>Long-lasting Intense Moisturizing Spf 20 - Vin</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.071; .016</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16252-525-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (16252-525-01)</PackageDescription>
<NDC11Code>16252-0525-01</NDC11Code>
<ProductNDC>16252-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acarbose</ProprietaryName>
<NonProprietaryName>Acarbose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077532</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ACARBOSE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16714-525-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-525-01) </PackageDescription>
<NDC11Code>16714-0525-01</NDC11Code>
<ProductNDC>16714-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074943</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) complies with USP Drug Release Test #2. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period.</Description>
</NDC>
<NDC>
<NDCCode>22431-525-01</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE (22431-525-01)</PackageDescription>
<NDC11Code>22431-0525-01</NDC11Code>
<ProductNDC>22431-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kitchen Citrus</ProprietaryName>
<ProprietaryNameSuffix>Foaming Hand</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Blue Cross Laboratories, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.46</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>31260-525-01</NDCCode>
<PackageDescription>136 kg in 1 DRUM (31260-525-01) </PackageDescription>
<NDC11Code>31260-0525-01</NDC11Code>
<ProductNDC>31260-525</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250722</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Gulbrandsen Technologies India Private Limited</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-JUL-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>31722-525-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01) </PackageDescription>
<NDC11Code>31722-0525-01</NDC11Code>
<ProductNDC>31722-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090061</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use:Finasteride tablets are not approved for the prevention of prostate cancer (1.3).</IndicationAndUsage>
<Description>Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize.</Description>
</NDC>
<NDC>
<NDCCode>42291-525-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-525-01) </PackageDescription>
<NDC11Code>42291-0525-01</NDC11Code>
<ProductNDC>42291-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078703</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules, USP, are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules, USP, are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP, are formulated to provide a sustained release of propranolol hydrochloride. Propranolol Hydrochloride Extended-Release Capsules, USP, are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each capsule for oral administration contains sugar spheres, ethylcellulose, hypromellose phthalate, povidone, diethyl phthalate, polyethylene glycol, titanium dioxide, ammonium hydroxide, potassium hydroxide, black iron oxide, and gelatin. The 80 mg, 120 mg, and 160 mg capsules contain red and yellow iron oxide. In addition, the 160 mg capsules contain FD&C Blue No. 2. These capsules comply with USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42806-525-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42806-525-01)</PackageDescription>
<NDC11Code>42806-0525-01</NDC11Code>
<ProductNDC>42806-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076868</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-03-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>46123-525-01</NDCCode>
<PackageDescription>334 L in 1 CYLINDER (46123-525-01) </PackageDescription>
<NDC11Code>46123-0525-01</NDC11Code>
<ProductNDC>46123-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen-carbon Dioxide Mixture</ProprietaryName>
<NonProprietaryName>Oxygen-carbon Dioxide Mixture</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19660101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>Roberts Oxygen Company, Inc.</LabelerName>
<SubstanceName>CARBON DIOXIDE; OXYGEN</SubstanceName>
<StrengthNumber>700; 300</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19660101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49574-525-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (49574-525-01) </PackageDescription>
<NDC11Code>49574-0525-01</NDC11Code>
<ProductNDC>49574-525</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20041001</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hunan Jiudian Pharmaceutical Co.,Ltd.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-OCT-04</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49967-525-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49967-525-01) / 40 mL in 1 TUBE</PackageDescription>
<NDC11Code>49967-0525-01</NDC11Code>
<ProductNDC>49967-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-525-01</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE, PLASTIC (50580-525-01) </PackageDescription>
<NDC11Code>50580-0525-01</NDC11Code>
<ProductNDC>50580-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tylenol Cold Max</ProprietaryName>
<ProprietaryNameSuffix>Day</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-525-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-525-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-525-01) </PackageDescription>
<NDC11Code>51079-0525-20</NDC11Code>
<ProductNDC>51079-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070709</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076930</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070709</StartMarketingDatePackage>
<EndMarketingDatePackage>20190430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51346-525-02</NDCCode>
<PackageDescription>100 POUCH in 1 CARTON (51346-525-02) > 2 mL in 1 POUCH (51346-525-01) </PackageDescription>
<NDC11Code>51346-0525-02</NDC11Code>
<ProductNDC>51346-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand And Nature Sanitizer Ge L Rose</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>1.09</StrengthNumber>
<StrengthUnit>g/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-525-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (51407-525-01) </PackageDescription>
<NDC11Code>51407-0525-01</NDC11Code>
<ProductNDC>51407-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074569</ApplicationNumber>
<LabelerName>Golden State Medical Supply Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52919-021-14</NDCCode>
<PackageDescription>525 AMPULE in 1 CARTON (52919-021-14) > 2 mL in 1 AMPULE (52919-021-01)</PackageDescription>
<NDC11Code>52919-0021-14</NDC11Code>
<ProductNDC>52919-021</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Polidocanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Siegfried Hameln GmbH</LabelerName>
<SubstanceName>POLIDOCANOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2018-10-18</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52919-022-14</NDCCode>
<PackageDescription>525 AMPULE in 1 CARTON (52919-022-14) > 2 mL in 1 AMPULE (52919-022-01)</PackageDescription>
<NDC11Code>52919-0022-14</NDC11Code>
<ProductNDC>52919-022</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Polidocanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Siegfried Hameln GmbH</LabelerName>
<SubstanceName>POLIDOCANOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-11-21</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52919-024-14</NDCCode>
<PackageDescription>525 AMPULE in 1 CARTON (52919-024-14) / 2 mL in 1 AMPULE (52919-024-01) </PackageDescription>
<NDC11Code>52919-0024-14</NDC11Code>
<ProductNDC>52919-024</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Polidocanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20190614</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Siegfried Hameln GmbH</LabelerName>
<SubstanceName>POLIDOCANOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-JUN-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>53208-525-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 BOX (53208-525-02) > 45 mL in 1 CONTAINER (53208-525-01)</PackageDescription>
<NDC11Code>53208-0525-02</NDC11Code>
<ProductNDC>53208-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The History Of Whoo Gongjinhyang Seol Whitening Sun</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Ensulizole, Polysilicone-15, Titanium Dioxide, Atractylodes Japonica Root Oil</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>LG Household and Healthcare, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; ENSULIZOLE; TITANIUM DIOXIDE; ATRACTYLODES JAPONICA ROOT OIL; POLYSILICONE-15</SubstanceName>
<StrengthNumber>6.117; 3.9; 2.48; .05; 3</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54860-525-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, SPRAY (54860-525-01) </PackageDescription>
<NDC11Code>54860-0525-01</NDC11Code>
<ProductNDC>54860-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Luxury Hand Sanitizer Cashmere Char</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251019</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251019</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-525-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55111-525-01) / 100 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0525-01</NDC11Code>
<ProductNDC>55111-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>59137-525-01</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (59137-525-01) / .35 mL in 1 PACKAGE (59137-525-00) </PackageDescription>
<NDC11Code>59137-0525-01</NDC11Code>
<ProductNDC>59137-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasuvo</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205776</ApplicationNumber>
<LabelerName>Medexus Pharma Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>17.5</StrengthNumber>
<StrengthUnit>mg/.35mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rasuvo is a folate analog metabolic inhibitor indicated for the: 1 Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1), 2 Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2).</IndicationAndUsage>
<Description>Rasuvo contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C20H22N8O5 M.W.= 454.45. Rasuvo contains methotrexate in a sterile, preservative-free, non-pyrogenic solution for a single subcutaneous injection. Rasuvo is an isotonic, clear, yellow to brown solution. Rasuvo contains the following inactive ingredients: sodium chloride 0.4% w/v; water for injections, sodium hydroxide and, if necessary, hydrochloric acid are added to adjust the pH to approximately 8.5.</Description>
</NDC>
<NDC>
<NDCCode>60429-525-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60429-525-01) </PackageDescription>
<NDC11Code>60429-0525-01</NDC11Code>
<ProductNDC>60429-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074869</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>