{
"NDC": [
{
"NDCCode": "64980-275-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (64980-275-03) ",
"NDC11Code": "64980-0275-03",
"ProductNDC": "64980-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voriconazole",
"NonProprietaryName": "Voriconazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206762",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "VORICONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161207",
"SamplePackage": "N",
"IndicationAndUsage": "VORICONAZOLE is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections:.",
"Description": "VORICONAZOLE® (voriconazole), an azole antifungal agent is available as a film-coated tablets for oral administration. The structural formula is. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VORICONAZOLE Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, povidone, magnesium stearate, maize starch and a coating containing hypromellose, titanium dioxide, lactose monohydrate, and triacetin."
},
{
"NDCCode": "16729-275-67",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03) ",
"NDC11Code": "16729-0275-67",
"ProductNDC": "16729-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bivalirudin",
"NonProprietaryName": "Bivalirudin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206551",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "BIVALIRUDIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181107",
"SamplePackage": "N",
"IndicationAndUsage": "Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.",
"Description": "Bivalirudin for injection contains bivalirudin which is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine. The active pharmaceutical ingredient is in the form of bivalirudin trifluoroacetate as a white powder. The chemical name for bivalirudin trifluoroacetate is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine trifluoroacetate (Figure 1). The molecular weight of bivalirudin is 2180 daltons (anhydrous free base peptide). Figure 1: Structure formula for bivalirudin trifluoroacetate. Bivalirudin for injection is supplied as a sterile white lyophilized cake, in single-dose vials. Each vial contains 250 mg bivalirudin, equivalent to an average of 275 mg of bivalirudin trifluoroacetate*, 125 mg mannitol, and sodium hydroxide to adjust the pH to 5 to 6 (equivalent of approximately 12.5 mg sodium). When reconstituted with Sterile Water for Injection, the product yields a clear, colorless to slightly yellow solution, pH 5 to 6. *The range of bivalirudin trifluoroacetate is 270 mg to 280 mg based on a range of trifluoroacetic acid composition of 1.7 to 2.6 equivalents."
},
{
"NDCCode": "43547-275-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-03) ",
"NDC11Code": "43547-0275-03",
"ProductNDC": "43547-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200292",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil Hydrochloride Tablets, USP, are available for oral administration in film-coated tablets containing 5 mg or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The film of 5 mg tablets coating contains FD&C Blue #2/INDIGO CARMINE ALUMINUM LAKE, hypromellose, polyethylene glycol, and titanium dioxide. The film of 10 mg tablets coating contains hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "54340-275-03",
"PackageDescription": "904 g in 1 CELLO PACK (54340-275-03)",
"NDC11Code": "54340-0275-03",
"ProductNDC": "54340-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Antibacterial Bar",
"NonProprietaryName": "Dial For Men Odor Armor",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "The Dial Corporation, A Henkel Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for washing to decrease the bacteria on the skin."
},
{
"NDCCode": "54436-275-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (54436-275-01) / .5 mL in 1 SYRINGE (54436-275-03) ",
"NDC11Code": "54436-0275-01",
"ProductNDC": "54436-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xyosted",
"NonProprietaryName": "Testosterone Enanthate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20181115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209863",
"LabelerName": "Antares Pharma, Inc.",
"SubstanceName": "TESTOSTERONE ENANTHATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181115",
"SamplePackage": "Y",
"IndicationAndUsage": "XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.",
"Description": "XYOSTED (testosterone enanthate) injection contains testosterone enanthate, an ester derivative of an endogenous androgen, testosterone. Testosterone enanthate is a white to creamy white crystalline powder described by the chemical name (17β)-17-[(1-Oxoheptyl) oxy]-androst-4-en-3-one. Testosterone enanthate has the molecular formula C26H40O3, the molecular weight 400.59, and the molecular structure with the chemical formula. XYOSTED (testosterone enanthate) injection is a sterile, preservative-free, and nonpyrogenic colorless to pale yellow solution supplied in a single-dose syringe assembled in a pressure-assisted autoinjector for subcutaneous administration. Each XYOSTED autoinjector contains 50 mg, 75 mg, or 100 mg of testosterone in sesame oil to form 0.5 mL solution providing three product strengths of 50 mg/0.5 mL, 75 mg/0.5 mL, and 100 mg/0.5 mL."
},
{
"NDCCode": "63545-275-03",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-275-03) ",
"NDC11Code": "63545-0275-03",
"ProductNDC": "63545-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Asparagus Officinalis",
"NonProprietaryName": "Asparagus Officinalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210408",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ASPARAGUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2021-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210408",
"SamplePackage": "N"
},
{
"NDCCode": "64679-275-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-275-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (64679-275-03) ",
"NDC11Code": "64679-0275-04",
"ProductNDC": "64679-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202498",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20121129",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "68428-275-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-275-03) ",
"NDC11Code": "68428-0275-03",
"ProductNDC": "68428-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Fluorica",
"NonProprietaryName": "Calcium Fluoride",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "72450-743-03",
"PackageDescription": "275 kg in 1 DRUM (72450-743-03) ",
"NDC11Code": "72450-0743-03",
"ProductNDC": "72450-743",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20180413",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Elementis SRL, Inc.",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": ".4",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-10-11",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "13-APR-18"
},
{
"NDCCode": "74688-001-03",
"PackageDescription": "275 g in 1 TANK (74688-001-03)",
"NDC11Code": "74688-0001-03",
"ProductNDC": "74688-001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20200406",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Marquis Energy-Wisconsin, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "74862-275-03",
"PackageDescription": "500 mL in 1 BOTTLE (74862-275-03) ",
"NDC11Code": "74862-0275-03",
"ProductNDC": "74862-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Yiwu Shining Cosmetics Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200427",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "76940-275-03",
"PackageDescription": "100 mL in 1 BOTTLE, SPRAY (76940-275-03) ",
"NDC11Code": "76940-0275-03",
"ProductNDC": "76940-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vapor Solutions & Labs LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77536-001-03",
"PackageDescription": "275 mL in 1 BOTTLE, PLASTIC (77536-001-03) ",
"NDC11Code": "77536-0001-03",
"ProductNDC": "77536-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing Gel By Cn Pharma",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Canadian National Pharma Group Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79903-275-03",
"PackageDescription": "88 mL in 1 BOTTLE, SPRAY (79903-275-03) ",
"NDC11Code": "79903-0275-03",
"ProductNDC": "79903-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Premium Saline",
"NonProprietaryName": "Sodium Chloride 0.65%",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20240930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Walmart Stores, Inc.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": ".65",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Provides instant, soothing relief to dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel, and use of decongestants/steroidal sprays."
},
{
"NDCCode": "84756-275-03",
"PackageDescription": "30 mL in 1 BOTTLE (84756-275-03) ",
"NDC11Code": "84756-0275-03",
"ProductNDC": "84756-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Hair Wax Stick",
"NonProprietaryName": "Trstay Hair Wax Stick",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"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": "64980-124-03",
"PackageDescription": "1 TUBE in 1 CARTON (64980-124-03) / 30 g in 1 TUBE",
"NDC11Code": "64980-0124-03",
"ProductNDC": "64980-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diflorasone Diacetate",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207440",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170227",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3, 20-dione 17,21-diacetate. The structural formula is represented below. C26H32F2O7 MW = 494.54 Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of propylene glycol, glyceryl monostearate and white petrolatum."
},
{
"NDCCode": "64980-171-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-171-03)",
"NDC11Code": "64980-0171-03",
"ProductNDC": "64980-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Disulfiram",
"NonProprietaryName": "Disulfiram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091619",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DISULFIRAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Acetyl Aldehyde Dehydrogenase Inhibitors [MoA], Aldehyde Dehydrogenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.",
"Description": "Disulfiram is an alcohol antagonist drug."
},
{
"NDCCode": "64980-172-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-172-03)",
"NDC11Code": "64980-0172-03",
"ProductNDC": "64980-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Disulfiram",
"NonProprietaryName": "Disulfiram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091619",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DISULFIRAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Acetyl Aldehyde Dehydrogenase Inhibitors [MoA], Aldehyde Dehydrogenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.",
"Description": "Disulfiram is an alcohol antagonist drug."
},
{
"NDCCode": "64980-179-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (64980-179-03) ",
"NDC11Code": "64980-0179-03",
"ProductNDC": "64980-179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flucytosine",
"NonProprietaryName": "Flucytosine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20111103",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201566",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "FLUCYTOSINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170413",
"EndMarketingDatePackage": "20190430",
"SamplePackage": "N"
},
{
"NDCCode": "64980-180-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (64980-180-03) ",
"NDC11Code": "64980-0180-03",
"ProductNDC": "64980-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flucytosine",
"NonProprietaryName": "Flucytosine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20111103",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201566",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "FLUCYTOSINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170413",
"EndMarketingDatePackage": "20190430",
"SamplePackage": "N"
},
{
"NDCCode": "64980-184-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-184-03)",
"NDC11Code": "64980-0184-03",
"ProductNDC": "64980-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Griseofulvin",
"NonProprietaryName": "Griseofulvin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202545",
"LabelerName": "Rising Pharmaceuticals, Inc",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate."
},
{
"NDCCode": "64980-185-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-185-03)",
"NDC11Code": "64980-0185-03",
"ProductNDC": "64980-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Griseofulvin",
"NonProprietaryName": "Griseofulvin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202545",
"LabelerName": "Rising Pharmaceuticals, Inc",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate."
},
{
"NDCCode": "64980-186-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-186-03)",
"NDC11Code": "64980-0186-03",
"ProductNDC": "64980-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Griseofulvin",
"NonProprietaryName": "Griseofulvin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202482",
"LabelerName": "Rising Pharmaceuticals Inc.",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely. Tinea corporis. Tinea pedis. Tinea cruris. Tinea barbae. Tinea capitis. Tinea unguium when caused by one or more of the following species of fungi. Epidermophyton floccosum. Microsporum audouinii. Microsporum canis. Microsporum gypseum. Trichophyton crateriform. Trichophyton gallinae. Trichophyton interdigitalis. Trichophyton megnini. Trichophyton mentagrophytes. Trichophyton rubrum. Trichophyton schoenleini. Trichophyton sulphureum. Trichophyton tonsurans. Trichophyton verrucosum. Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. Griseofulvin is not effective in the following. Bacterial infections. Candidiasis (Moniliasis). Histoplasmosis. Actinomycosis. Sporotrichosis. Chromoblastomycosis. Coccidioidomycosis. North American Blastomycosis. Cryptococcosis (Torulosis). Tinea versicolor. Nocardiosis. The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.",
"Description": "Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic derived from a species of Penicillium. The chemical name of griseofulvin is 7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexane]-3-4’-dione. Its structural formula is. C17H17ClO6 M.W = 352.77. Griseofulvin occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 µm in diameter. Griseofulvin Tablets, USP (microsize) 500 mg are white, capsule shaped, bisected tablets, debossed with ‘Σ’ and ‘12’ on either side of the bisection and plain on the other side. Each Griseofulvin Tablet, USP (microsize) 500 mg contains 500 mg of griseofulvin microsize, and also contains corn starch, povidone, polyethylene glycol 400, polyethylene glycol 8000, lactose monohydrate, crospovidone, silicon dioxide and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "64980-190-03",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (64980-190-03) ",
"NDC11Code": "64980-0190-03",
"ProductNDC": "64980-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091451",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120921",
"SamplePackage": "N"
},
{
"NDCCode": "64980-205-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-205-03) ",
"NDC11Code": "64980-0205-03",
"ProductNDC": "64980-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithium Carbonate",
"NonProprietaryName": "Lithium Carbonate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204779",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LITHIUM CARBONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160323",
"SamplePackage": "N",
"IndicationAndUsage": "Lithium carbonate extended-release tablets is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.",
"Description": "Lithium carbonate extended-release tablets USP contain lithium carbonate, a white odorless alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach-colored, round biconvex film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of black ink S-1-277001 (contains Black Iron Oxide, Propylene Glycol, Shellac Glaze (Modified) IN SD-45), calcium stearate, hypromellose, opadry pink (carnauba wax, FD&C Blue No. 2 Aluminium Lake, FD&C Red No. 40 Aluminium Lake, FD&C Yellow No. 6 Aluminium Lake, hypromellose, polyethylene glycol, propylene glycol, titanium dioxide), povidone and sodium lauryl sulfate."
},
{
"NDCCode": "64980-209-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-209-03) ",
"NDC11Code": "64980-0209-03",
"ProductNDC": "64980-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206121",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220329",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
"Description": "Oxybutynin chloride USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet USP contains 5 mg, 10 mg or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride USP is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablet, USP also contains the following inert ingredients: polyethylene oxide, hypromellose, sodium chloride, butylated hydroxytoluene, ferric oxide (yellow), ferric oxide (red), ferric oxide (black), colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, lactose monohydrate, triacetin, shellac, and propylene glycol. System Components and Performance Oxybutynin chloride extended-release tablets USP uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. This expansion pushes the suspended drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of oxybutynin chloride extended-release tablets depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. Product meets USP Dissolution Test 6."
},
{
"NDCCode": "64980-220-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (64980-220-03) ",
"NDC11Code": "64980-0220-03",
"ProductNDC": "64980-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyridostigmine Bromide",
"NonProprietaryName": "Pyridostigmine Bromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205464",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "PYRIDOSTIGMINE BROMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170815",
"SamplePackage": "N",
"Description": "Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, Pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide is available in the following form: Extended-release tablets containing 180 mg Pyridostigmine bromide, each tablet also contains colloidal silicon dioxide, carnauba wax, tribasic calcium phosphate, zein (corn protein) and magnesium stearate. ACTIONS. Pyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine (Prostigmin®), but differs from it in certain clinically significant respects, for example, Pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.INDICATION. Pyridostigmine bromide is useful in the treatment of myasthenia gravis."
},
{
"NDCCode": "64980-224-03",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (64980-224-03)",
"NDC11Code": "64980-0224-03",
"ProductNDC": "64980-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dutasteride",
"NonProprietaryName": "Dutasteride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20151120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202530",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "DUTASTERIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "DUTASTERIDE is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.",
"Description": "DUTASTERIDE is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl) phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each DUTASTERIDE soft gelatin capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible black ink."
},
{
"NDCCode": "64980-225-03",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (64980-225-03)",
"NDC11Code": "64980-0225-03",
"ProductNDC": "64980-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paricalcitol",
"NonProprietaryName": "Paricalcitol",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202124",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "PARICALCITOL",
"StrengthNumber": "1",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS],Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease. Paricalcitol capsules are available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides (Neobee Oil M-5), ethanol, butylated hydroxytoluene, and lecithin soy. The capsule shell is composed of ammonium hydroxide, gelatin, glycerin, macrogol (polyethylene glycol), propylene glycol, polyvinyl acetate phthalate, titanium dioxide, iron oxide black, iron oxide red (2 microgram capsules only), iron oxide yellow (4 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula."
},
{
"NDCCode": "64980-226-03",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (64980-226-03)",
"NDC11Code": "64980-0226-03",
"ProductNDC": "64980-226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paricalcitol",
"NonProprietaryName": "Paricalcitol",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202124",
"LabelerName": "Rising Pharmaceuticals, Inc.",
"SubstanceName": "PARICALCITOL",
"StrengthNumber": "2",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS],Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease. Paricalcitol capsules are available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides (Neobee Oil M-5), ethanol, butylated hydroxytoluene, and lecithin soy. The capsule shell is composed of ammonium hydroxide, gelatin, glycerin, macrogol (polyethylene glycol), propylene glycol, polyvinyl acetate phthalate, titanium dioxide, iron oxide black, iron oxide red (2 microgram capsules only), iron oxide yellow (4 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>64980-275-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (64980-275-03) </PackageDescription>
<NDC11Code>64980-0275-03</NDC11Code>
<ProductNDC>64980-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voriconazole</ProprietaryName>
<NonProprietaryName>Voriconazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206762</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VORICONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VORICONAZOLE is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections:.</IndicationAndUsage>
<Description>VORICONAZOLE® (voriconazole), an azole antifungal agent is available as a film-coated tablets for oral administration. The structural formula is. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. VORICONAZOLE Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch, colloidal silicon dioxide, croscarmellose sodium, povidone, magnesium stearate, maize starch and a coating containing hypromellose, titanium dioxide, lactose monohydrate, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>16729-275-67</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03) </PackageDescription>
<NDC11Code>16729-0275-67</NDC11Code>
<ProductNDC>16729-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bivalirudin</ProprietaryName>
<NonProprietaryName>Bivalirudin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206551</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>BIVALIRUDIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.</IndicationAndUsage>
<Description>Bivalirudin for injection contains bivalirudin which is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine. The active pharmaceutical ingredient is in the form of bivalirudin trifluoroacetate as a white powder. The chemical name for bivalirudin trifluoroacetate is D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine trifluoroacetate (Figure 1). The molecular weight of bivalirudin is 2180 daltons (anhydrous free base peptide). Figure 1: Structure formula for bivalirudin trifluoroacetate. Bivalirudin for injection is supplied as a sterile white lyophilized cake, in single-dose vials. Each vial contains 250 mg bivalirudin, equivalent to an average of 275 mg of bivalirudin trifluoroacetate*, 125 mg mannitol, and sodium hydroxide to adjust the pH to 5 to 6 (equivalent of approximately 12.5 mg sodium). When reconstituted with Sterile Water for Injection, the product yields a clear, colorless to slightly yellow solution, pH 5 to 6. *The range of bivalirudin trifluoroacetate is 270 mg to 280 mg based on a range of trifluoroacetic acid composition of 1.7 to 2.6 equivalents.</Description>
</NDC>
<NDC>
<NDCCode>43547-275-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-03) </PackageDescription>
<NDC11Code>43547-0275-03</NDC11Code>
<ProductNDC>43547-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200292</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil Hydrochloride Tablets, USP, are available for oral administration in film-coated tablets containing 5 mg or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The film of 5 mg tablets coating contains FD&C Blue #2/INDIGO CARMINE ALUMINUM LAKE, hypromellose, polyethylene glycol, and titanium dioxide. The film of 10 mg tablets coating contains hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54340-275-03</NDCCode>
<PackageDescription>904 g in 1 CELLO PACK (54340-275-03)</PackageDescription>
<NDC11Code>54340-0275-03</NDC11Code>
<ProductNDC>54340-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Dial For Men Odor Armor</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>The Dial Corporation, A Henkel Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for washing to decrease the bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54436-275-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (54436-275-01) / .5 mL in 1 SYRINGE (54436-275-03) </PackageDescription>
<NDC11Code>54436-0275-01</NDC11Code>
<ProductNDC>54436-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xyosted</ProprietaryName>
<NonProprietaryName>Testosterone Enanthate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209863</ApplicationNumber>
<LabelerName>Antares Pharma, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE ENANTHATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181115</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.</IndicationAndUsage>
<Description>XYOSTED (testosterone enanthate) injection contains testosterone enanthate, an ester derivative of an endogenous androgen, testosterone. Testosterone enanthate is a white to creamy white crystalline powder described by the chemical name (17β)-17-[(1-Oxoheptyl) oxy]-androst-4-en-3-one. Testosterone enanthate has the molecular formula C26H40O3, the molecular weight 400.59, and the molecular structure with the chemical formula. XYOSTED (testosterone enanthate) injection is a sterile, preservative-free, and nonpyrogenic colorless to pale yellow solution supplied in a single-dose syringe assembled in a pressure-assisted autoinjector for subcutaneous administration. Each XYOSTED autoinjector contains 50 mg, 75 mg, or 100 mg of testosterone in sesame oil to form 0.5 mL solution providing three product strengths of 50 mg/0.5 mL, 75 mg/0.5 mL, and 100 mg/0.5 mL.</Description>
</NDC>
<NDC>
<NDCCode>63545-275-03</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-275-03) </PackageDescription>
<NDC11Code>63545-0275-03</NDC11Code>
<ProductNDC>63545-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Asparagus Officinalis</ProprietaryName>
<NonProprietaryName>Asparagus Officinalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210408</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ASPARAGUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-275-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-275-04) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (64679-275-03) </PackageDescription>
<NDC11Code>64679-0275-04</NDC11Code>
<ProductNDC>64679-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202498</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablet is an antiepileptic drug (AED) indicated for: 1 Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water and in 0.1M hydrochloric acid. The structural formula is:. Lamotrigine extended-release tablets are supplied for oral administration as 25 mg (yellow, enteric-coated, circular shaped tablet), 50 mg (pink, enteric-coated, circular shaped tablet), 100 mg (light brown, enteric-coated, circular shaped tablet), 200 mg (pink, enteric-coated, circular shaped tablet), and 300 mg (pink, enteric-coated, circular shaped tablet). Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: diethyl phthalate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, talc, titanium dioxide, iron oxide yellow for (25 mg and 100 mg) and iron oxide red for (50 mg, 100 mg, 200 mg, and 300 mg). Lamotrigine extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>68428-275-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-275-03) </PackageDescription>
<NDC11Code>68428-0275-03</NDC11Code>
<ProductNDC>68428-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Fluorica</ProprietaryName>
<NonProprietaryName>Calcium Fluoride</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72450-743-03</NDCCode>
<PackageDescription>275 kg in 1 DRUM (72450-743-03) </PackageDescription>
<NDC11Code>72450-0743-03</NDC11Code>
<ProductNDC>72450-743</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20180413</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Elementis SRL, Inc.</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-10-11</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-APR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>74688-001-03</NDCCode>
<PackageDescription>275 g in 1 TANK (74688-001-03)</PackageDescription>
<NDC11Code>74688-0001-03</NDC11Code>
<ProductNDC>74688-001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20200406</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Marquis Energy-Wisconsin, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>74862-275-03</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (74862-275-03) </PackageDescription>
<NDC11Code>74862-0275-03</NDC11Code>
<ProductNDC>74862-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Yiwu Shining Cosmetics Co., Ltd.</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>20200427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76940-275-03</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, SPRAY (76940-275-03) </PackageDescription>
<NDC11Code>76940-0275-03</NDC11Code>
<ProductNDC>76940-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vapor Solutions & Labs LLC</LabelerName>
<SubstanceName>ISOPROPYL 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>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77536-001-03</NDCCode>
<PackageDescription>275 mL in 1 BOTTLE, PLASTIC (77536-001-03) </PackageDescription>
<NDC11Code>77536-0001-03</NDC11Code>
<ProductNDC>77536-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing Gel By Cn Pharma</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Canadian National Pharma Group Inc</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>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79903-275-03</NDCCode>
<PackageDescription>88 mL in 1 BOTTLE, SPRAY (79903-275-03) </PackageDescription>
<NDC11Code>79903-0275-03</NDC11Code>
<ProductNDC>79903-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Premium Saline</ProprietaryName>
<NonProprietaryName>Sodium Chloride 0.65%</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20240930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Walmart Stores, Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.65</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Provides instant, soothing relief to dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel, and use of decongestants/steroidal sprays.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-275-03</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (84756-275-03) </PackageDescription>
<NDC11Code>84756-0275-03</NDC11Code>
<ProductNDC>84756-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Hair Wax Stick</ProprietaryName>
<NonProprietaryName>Trstay Hair Wax Stick</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Luoxin E� Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</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>64980-124-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (64980-124-03) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>64980-0124-03</NDC11Code>
<ProductNDC>64980-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diflorasone Diacetate</ProprietaryName>
<NonProprietaryName>Diflorasone Diacetate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207440</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>DIFLORASONE DIACETATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3, 20-dione 17,21-diacetate. The structural formula is represented below. C26H32F2O7 MW = 494.54 Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of propylene glycol, glyceryl monostearate and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>64980-171-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-171-03)</PackageDescription>
<NDC11Code>64980-0171-03</NDC11Code>
<ProductNDC>64980-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Disulfiram</ProprietaryName>
<NonProprietaryName>Disulfiram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091619</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DISULFIRAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Acetyl Aldehyde Dehydrogenase Inhibitors [MoA], Aldehyde Dehydrogenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.</IndicationAndUsage>
<Description>Disulfiram is an alcohol antagonist drug.</Description>
</NDC>
<NDC>
<NDCCode>64980-172-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-172-03)</PackageDescription>
<NDC11Code>64980-0172-03</NDC11Code>
<ProductNDC>64980-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Disulfiram</ProprietaryName>
<NonProprietaryName>Disulfiram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091619</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DISULFIRAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Acetyl Aldehyde Dehydrogenase Inhibitors [MoA], Aldehyde Dehydrogenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.</IndicationAndUsage>
<Description>Disulfiram is an alcohol antagonist drug.</Description>
</NDC>
<NDC>
<NDCCode>64980-179-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (64980-179-03) </PackageDescription>
<NDC11Code>64980-0179-03</NDC11Code>
<ProductNDC>64980-179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flucytosine</ProprietaryName>
<NonProprietaryName>Flucytosine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111103</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201566</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUCYTOSINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170413</StartMarketingDatePackage>
<EndMarketingDatePackage>20190430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-180-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (64980-180-03) </PackageDescription>
<NDC11Code>64980-0180-03</NDC11Code>
<ProductNDC>64980-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flucytosine</ProprietaryName>
<NonProprietaryName>Flucytosine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111103</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201566</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUCYTOSINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170413</StartMarketingDatePackage>
<EndMarketingDatePackage>20190430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-184-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-184-03)</PackageDescription>
<NDC11Code>64980-0184-03</NDC11Code>
<ProductNDC>64980-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Griseofulvin</ProprietaryName>
<NonProprietaryName>Griseofulvin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202545</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>64980-185-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-185-03)</PackageDescription>
<NDC11Code>64980-0185-03</NDC11Code>
<ProductNDC>64980-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Griseofulvin</ProprietaryName>
<NonProprietaryName>Griseofulvin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202545</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. C17H17ClO6 M.W. 352.77. Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>64980-186-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-186-03)</PackageDescription>
<NDC11Code>64980-0186-03</NDC11Code>
<ProductNDC>64980-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Griseofulvin</ProprietaryName>
<NonProprietaryName>Griseofulvin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202482</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely. Tinea corporis. Tinea pedis. Tinea cruris. Tinea barbae. Tinea capitis. Tinea unguium when caused by one or more of the following species of fungi. Epidermophyton floccosum. Microsporum audouinii. Microsporum canis. Microsporum gypseum. Trichophyton crateriform. Trichophyton gallinae. Trichophyton interdigitalis. Trichophyton megnini. Trichophyton mentagrophytes. Trichophyton rubrum. Trichophyton schoenleini. Trichophyton sulphureum. Trichophyton tonsurans. Trichophyton verrucosum. Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. Griseofulvin is not effective in the following. Bacterial infections. Candidiasis (Moniliasis). Histoplasmosis. Actinomycosis. Sporotrichosis. Chromoblastomycosis. Coccidioidomycosis. North American Blastomycosis. Cryptococcosis (Torulosis). Tinea versicolor. Nocardiosis. The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.</IndicationAndUsage>
<Description>Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic derived from a species of Penicillium. The chemical name of griseofulvin is 7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexane]-3-4’-dione. Its structural formula is. C17H17ClO6 M.W = 352.77. Griseofulvin occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 µm in diameter. Griseofulvin Tablets, USP (microsize) 500 mg are white, capsule shaped, bisected tablets, debossed with ‘Σ’ and ‘12’ on either side of the bisection and plain on the other side. Each Griseofulvin Tablet, USP (microsize) 500 mg contains 500 mg of griseofulvin microsize, and also contains corn starch, povidone, polyethylene glycol 400, polyethylene glycol 8000, lactose monohydrate, crospovidone, silicon dioxide and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64980-190-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (64980-190-03) </PackageDescription>
<NDC11Code>64980-0190-03</NDC11Code>
<ProductNDC>64980-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091451</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-205-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-205-03) </PackageDescription>
<NDC11Code>64980-0205-03</NDC11Code>
<ProductNDC>64980-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithium Carbonate</ProprietaryName>
<NonProprietaryName>Lithium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204779</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lithium carbonate extended-release tablets is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.</IndicationAndUsage>
<Description>Lithium carbonate extended-release tablets USP contain lithium carbonate, a white odorless alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach-colored, round biconvex film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of black ink S-1-277001 (contains Black Iron Oxide, Propylene Glycol, Shellac Glaze (Modified) IN SD-45), calcium stearate, hypromellose, opadry pink (carnauba wax, FD&C Blue No. 2 Aluminium Lake, FD&C Red No. 40 Aluminium Lake, FD&C Yellow No. 6 Aluminium Lake, hypromellose, polyethylene glycol, propylene glycol, titanium dioxide), povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>64980-209-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-209-03) </PackageDescription>
<NDC11Code>64980-0209-03</NDC11Code>
<ProductNDC>64980-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206121</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).</IndicationAndUsage>
<Description>Oxybutynin chloride USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet USP contains 5 mg, 10 mg or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride USP is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablet, USP also contains the following inert ingredients: polyethylene oxide, hypromellose, sodium chloride, butylated hydroxytoluene, ferric oxide (yellow), ferric oxide (red), ferric oxide (black), colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, lactose monohydrate, triacetin, shellac, and propylene glycol. System Components and Performance Oxybutynin chloride extended-release tablets USP uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. This expansion pushes the suspended drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of oxybutynin chloride extended-release tablets depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. Product meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>64980-220-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (64980-220-03) </PackageDescription>
<NDC11Code>64980-0220-03</NDC11Code>
<ProductNDC>64980-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyridostigmine Bromide</ProprietaryName>
<NonProprietaryName>Pyridostigmine Bromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205464</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>PYRIDOSTIGMINE BROMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, Pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide is available in the following form: Extended-release tablets containing 180 mg Pyridostigmine bromide, each tablet also contains colloidal silicon dioxide, carnauba wax, tribasic calcium phosphate, zein (corn protein) and magnesium stearate. ACTIONS. Pyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine (Prostigmin®), but differs from it in certain clinically significant respects, for example, Pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.INDICATION. Pyridostigmine bromide is useful in the treatment of myasthenia gravis.</Description>
</NDC>
<NDC>
<NDCCode>64980-224-03</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (64980-224-03)</PackageDescription>
<NDC11Code>64980-0224-03</NDC11Code>
<ProductNDC>64980-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dutasteride</ProprietaryName>
<NonProprietaryName>Dutasteride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202530</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DUTASTERIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>DUTASTERIDE is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1): 1 improve symptoms,, 2 reduce the risk of acute urinary retention, and, 3 reduce the risk of the need for BPH-related surgery.</IndicationAndUsage>
<Description>DUTASTERIDE is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl) phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each DUTASTERIDE soft gelatin capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>64980-225-03</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (64980-225-03)</PackageDescription>
<NDC11Code>64980-0225-03</NDC11Code>
<ProductNDC>64980-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paricalcitol</ProprietaryName>
<NonProprietaryName>Paricalcitol</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202124</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PARICALCITOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS],Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease. Paricalcitol capsules are available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides (Neobee Oil M-5), ethanol, butylated hydroxytoluene, and lecithin soy. The capsule shell is composed of ammonium hydroxide, gelatin, glycerin, macrogol (polyethylene glycol), propylene glycol, polyvinyl acetate phthalate, titanium dioxide, iron oxide black, iron oxide red (2 microgram capsules only), iron oxide yellow (4 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>64980-226-03</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (64980-226-03)</PackageDescription>
<NDC11Code>64980-0226-03</NDC11Code>
<ProductNDC>64980-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paricalcitol</ProprietaryName>
<NonProprietaryName>Paricalcitol</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202124</ApplicationNumber>
<LabelerName>Rising Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PARICALCITOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS],Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Paricalcitol, USP, the active ingredient in paricalcitol capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease. Paricalcitol capsules are available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides (Neobee Oil M-5), ethanol, butylated hydroxytoluene, and lecithin soy. The capsule shell is composed of ammonium hydroxide, gelatin, glycerin, macrogol (polyethylene glycol), propylene glycol, polyvinyl acetate phthalate, titanium dioxide, iron oxide black, iron oxide red (2 microgram capsules only), iron oxide yellow (4 microgram capsules only), and water. Paricalcitol is a white, crystalline powder with the empirical formula of C27H44O3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula.</Description>
</NDC>
</NDCList>