{
"NDC": [
{
"NDCCode": "70710-1901-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (70710-1901-3) ",
"NDC11Code": "70710-1901-03",
"ProductNDC": "70710-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sitagliptin",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA211566",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "SITAGLIPTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin Tablets is not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin Tablets. [see Warnings and Precautions (5.1)].",
"Description": "Sitagliptin Tablets contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine. The empirical formula is C16H15F6N5O and the molecular weight is 407.31. The structural formula is. Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of sitagliptin contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "70710-1901-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (70710-1901-9) ",
"NDC11Code": "70710-1901-09",
"ProductNDC": "70710-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sitagliptin",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA211566",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "SITAGLIPTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin Tablets is not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin Tablets. [see Warnings and Precautions (5.1)].",
"Description": "Sitagliptin Tablets contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine. The empirical formula is C16H15F6N5O and the molecular weight is 407.31. The structural formula is. Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of sitagliptin contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "0573-1901-30",
"PackageDescription": "3 CYLINDER in 1 BLISTER PACK (0573-1901-30) > 4 g in 1 CYLINDER",
"NDC11Code": "00573-1901-30",
"ProductNDC": "0573-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chapstick Classic Original",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Pfizer Consumer Healthcare",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "450",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "10637-1901-1",
"PackageDescription": "28.3 g in 1 TUBE (10637-1901-1) ",
"NDC11Code": "10637-1901-01",
"ProductNDC": "10637-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Fab Ultra Repair Intense Hydration Skin Protectant",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Port Jervis Laboratories, Inc",
"SubstanceName": "OATMEAL",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites."
},
{
"NDCCode": "24737-1901-3",
"PackageDescription": "82 g in 1 BOTTLE, WITH APPLICATOR (24737-1901-3) ",
"NDC11Code": "24737-1901-03",
"ProductNDC": "24737-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Osteo Bi-flex Roll-on",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190331",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "The Nature's Bounty Company",
"SubstanceName": "MENTHOL",
"StrengthNumber": "8",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: ●arthritis ●simple backache ●strains ●bruises ●sprains."
},
{
"NDCCode": "36987-1901-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1901-3)",
"NDC11Code": "36987-1901-03",
"ProductNDC": "36987-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aspergillus Terreus",
"NonProprietaryName": "Aspergillus Terreus",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ASPERGILLUS TERREUS",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1901-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-1901-3) ",
"NDC11Code": "37662-1901-03",
"ProductNDC": "37662-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Sulphuricum",
"NonProprietaryName": "Natrum Sulphuricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221108",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SODIUM SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221108",
"SamplePackage": "N"
},
{
"NDCCode": "38779-1901-3",
"PackageDescription": "5 g in 1 BOTTLE, GLASS (38779-1901-3) ",
"NDC11Code": "38779-1901-03",
"ProductNDC": "38779-1901",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Estradiol Cypionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140826",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "ESTRADIOL CYPIONATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "09-SEP-16"
},
{
"NDCCode": "54565-1901-4",
"PackageDescription": "1 CONTAINER in 1 CARTON (54565-1901-4) > 62 g in 1 CONTAINER (54565-1901-3)",
"NDC11Code": "54565-1901-04",
"ProductNDC": "54565-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree Clinical Antiperspirant And Deodorant",
"ProprietaryNameSuffix": "Sheer Powder",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"LabelerName": "Les Emballages Knowlton Inc.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59116-1901-3",
"PackageDescription": "30 kg in 1 DRUM (59116-1901-3)",
"NDC11Code": "59116-1901-03",
"ProductNDC": "59116-1901",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Torasemide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121026",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Cambrex Charles City, Inc",
"SubstanceName": "TORSEMIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68071-1901-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68071-1901-3)",
"NDC11Code": "68071-1901-03",
"ProductNDC": "68071-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078332",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68210-1901-3",
"PackageDescription": "1000 CAPSULE, LIQUID FILLED in 1 BOX (68210-1901-3)",
"NDC11Code": "68210-1901-03",
"ProductNDC": "68210-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simethicone",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "SPIRIT PHARMACEUTICALS,LLC",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas."
},
{
"NDCCode": "70518-1901-3",
"PackageDescription": "50 POUCH in 1 BOX (70518-1901-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2) ",
"NDC11Code": "70518-1901-03",
"ProductNDC": "70518-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260707",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "71335-1901-3",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (71335-1901-3) ",
"NDC11Code": "71335-1901-03",
"ProductNDC": "71335-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203482",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241211",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. Each capsule for oral administration contains either 7.5 mg, 15 mg, 22.5 mg or 30 mg temazepam, USP. The inactive ingredients include: ammonia, black iron oxide, butyl alcohol, croscarmellose sodium, dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Additionally, the 7.5 mg capsule contains D&C Red #28 and FD&C Blue #1 and the 15 mg and 22.5 mg capsules contain FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6."
},
{
"NDCCode": "74787-1901-3",
"PackageDescription": "100 mL in 1 BOTTLE, PUMP (74787-1901-3) ",
"NDC11Code": "74787-1901-03",
"ProductNDC": "74787-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exalthemp Hot And Cold Pain Cream",
"NonProprietaryName": "Hot And Cold Pain Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220623",
"EndMarketingDate": "20250120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "BioSerene Inc.",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "10; 4",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220623",
"EndMarketingDatePackage": "20250120",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backaches, strains, bruises, sprains, and pulled muscles."
},
{
"NDCCode": "0378-1901-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1901-01) ",
"NDC11Code": "00378-1901-01",
"ProductNDC": "0378-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076577",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030911",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets' effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of midodrine hydrochloride is 290.7. Its structural formula and molecular formula are. Midodrine hydrochloride, USP is an odorless, white, crystalline powder. It is soluble in water and sparingly soluble in methanol and has a pKa of 7.8 (0.3% aqueous solution) and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range of 200° to 203°C. Each midodrine hydrochloride tablet, USP for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate."
},
{
"NDCCode": "43742-1901-1",
"PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (43742-1901-1) ",
"NDC11Code": "43742-1901-01",
"ProductNDC": "43742-1901",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Herpes Zoster Nosode",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20210427",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals,Inc.",
"SubstanceName": "HUMAN HERPESVIRUS 3",
"StrengthNumber": "60",
"StrengthUnit": "[hp_X]/mL",
"Status": "Unfinished",
"LastUpdate": "2024-10-23",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "27-APR-21"
},
{
"NDCCode": "70710-1000-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1000-3) ",
"NDC11Code": "70710-1000-03",
"ProductNDC": "70710-1000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1001-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1001-3) ",
"NDC11Code": "70710-1001-03",
"ProductNDC": "70710-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1002-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1002-3) ",
"NDC11Code": "70710-1002-03",
"ProductNDC": "70710-1002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208971",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide."
},
{
"NDCCode": "70710-1011-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) ",
"NDC11Code": "70710-1011-03",
"ProductNDC": "70710-1011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1012-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) ",
"NDC11Code": "70710-1012-03",
"ProductNDC": "70710-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1013-3",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1013-3) ",
"NDC11Code": "70710-1013-03",
"ProductNDC": "70710-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208882",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210506",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).",
"Description": "Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "70710-1014-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (70710-1014-3) ",
"NDC11Code": "70710-1014-03",
"ProductNDC": "70710-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210189",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "Y",
"IndicationAndUsage": "Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "70710-1021-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (70710-1021-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70710-1021-03",
"ProductNDC": "70710-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albendazole",
"NonProprietaryName": "Albendazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208979",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ALBENDAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200527",
"SamplePackage": "N",
"IndicationAndUsage": "Albendazole tablets are an anthelmintic drug indicated for: 1 Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2 Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).",
"Description": "Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5 - (propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water. Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide."
},
{
"NDCCode": "70710-1022-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1022-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1022-08",
"ProductNDC": "70710-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1023-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1023-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1023-08",
"ProductNDC": "70710-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1024-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1024-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1024-08",
"ProductNDC": "70710-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1025-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70710-1025-8) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1025-08",
"ProductNDC": "70710-1025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1039-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3) ",
"NDC11Code": "70710-1039-03",
"ProductNDC": "70710-1039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208949",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230117",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate extended-release capsules are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70710-1901-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70710-1901-3) </PackageDescription>
<NDC11Code>70710-1901-03</NDC11Code>
<ProductNDC>70710-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sitagliptin</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA211566</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>SITAGLIPTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin Tablets is not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin Tablets. [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Sitagliptin Tablets contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine. The empirical formula is C16H15F6N5O and the molecular weight is 407.31. The structural formula is. Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of sitagliptin contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>70710-1901-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70710-1901-9) </PackageDescription>
<NDC11Code>70710-1901-09</NDC11Code>
<ProductNDC>70710-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sitagliptin</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA211566</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>SITAGLIPTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use. Sitagliptin Tablets is not recommended in patients with type 1 diabetes mellitus. Sitagliptin Tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Sitagliptin Tablets. [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Sitagliptin Tablets contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine. The empirical formula is C16H15F6N5O and the molecular weight is 407.31. The structural formula is. Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of sitagliptin contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0573-1901-30</NDCCode>
<PackageDescription>3 CYLINDER in 1 BLISTER PACK (0573-1901-30) > 4 g in 1 CYLINDER</PackageDescription>
<NDC11Code>00573-1901-30</NDC11Code>
<ProductNDC>0573-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chapstick Classic Original</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Pfizer Consumer Healthcare</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10637-1901-1</NDCCode>
<PackageDescription>28.3 g in 1 TUBE (10637-1901-1) </PackageDescription>
<NDC11Code>10637-1901-01</NDC11Code>
<ProductNDC>10637-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Beauty Fab Ultra Repair Intense Hydration Skin Protectant</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Port Jervis Laboratories, Inc</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24737-1901-3</NDCCode>
<PackageDescription>82 g in 1 BOTTLE, WITH APPLICATOR (24737-1901-3) </PackageDescription>
<NDC11Code>24737-1901-03</NDC11Code>
<ProductNDC>24737-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Osteo Bi-flex Roll-on</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>The Nature's Bounty Company</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: ●arthritis ●simple backache ●strains ●bruises ●sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-1901-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1901-3)</PackageDescription>
<NDC11Code>36987-1901-03</NDC11Code>
<ProductNDC>36987-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aspergillus Terreus</ProprietaryName>
<NonProprietaryName>Aspergillus Terreus</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS TERREUS</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1901-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-1901-3) </PackageDescription>
<NDC11Code>37662-1901-03</NDC11Code>
<ProductNDC>37662-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Sulphuricum</ProprietaryName>
<NonProprietaryName>Natrum Sulphuricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SODIUM SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>38779-1901-3</NDCCode>
<PackageDescription>5 g in 1 BOTTLE, GLASS (38779-1901-3) </PackageDescription>
<NDC11Code>38779-1901-03</NDC11Code>
<ProductNDC>38779-1901</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Estradiol Cypionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140826</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>ESTRADIOL CYPIONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-SEP-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>54565-1901-4</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (54565-1901-4) > 62 g in 1 CONTAINER (54565-1901-3)</PackageDescription>
<NDC11Code>54565-1901-04</NDC11Code>
<ProductNDC>54565-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree Clinical Antiperspirant And Deodorant</ProprietaryName>
<ProprietaryNameSuffix>Sheer Powder</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<LabelerName>Les Emballages Knowlton Inc.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59116-1901-3</NDCCode>
<PackageDescription>30 kg in 1 DRUM (59116-1901-3)</PackageDescription>
<NDC11Code>59116-1901-03</NDC11Code>
<ProductNDC>59116-1901</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Torasemide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20121026</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cambrex Charles City, Inc</LabelerName>
<SubstanceName>TORSEMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1901-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68071-1901-3)</PackageDescription>
<NDC11Code>68071-1901-03</NDC11Code>
<ProductNDC>68071-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078332</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68210-1901-3</NDCCode>
<PackageDescription>1000 CAPSULE, LIQUID FILLED in 1 BOX (68210-1901-3)</PackageDescription>
<NDC11Code>68210-1901-03</NDC11Code>
<ProductNDC>68210-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simethicone</ProprietaryName>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>SPIRIT PHARMACEUTICALS,LLC</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70518-1901-3</NDCCode>
<PackageDescription>50 POUCH in 1 BOX (70518-1901-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2) </PackageDescription>
<NDC11Code>70518-1901-03</NDC11Code>
<ProductNDC>70518-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>71335-1901-3</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (71335-1901-3) </PackageDescription>
<NDC11Code>71335-1901-03</NDC11Code>
<ProductNDC>71335-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203482</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. Each capsule for oral administration contains either 7.5 mg, 15 mg, 22.5 mg or 30 mg temazepam, USP. The inactive ingredients include: ammonia, black iron oxide, butyl alcohol, croscarmellose sodium, dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Additionally, the 7.5 mg capsule contains D&C Red #28 and FD&C Blue #1 and the 15 mg and 22.5 mg capsules contain FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>74787-1901-3</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, PUMP (74787-1901-3) </PackageDescription>
<NDC11Code>74787-1901-03</NDC11Code>
<ProductNDC>74787-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exalthemp Hot And Cold Pain Cream</ProprietaryName>
<NonProprietaryName>Hot And Cold Pain Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<EndMarketingDate>20250120</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>BioSerene Inc.</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<EndMarketingDatePackage>20250120</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backaches, strains, bruises, sprains, and pulled muscles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-1901-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-1901-01) </PackageDescription>
<NDC11Code>00378-1901-01</NDC11Code>
<ProductNDC>0378-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076577</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets' effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of midodrine hydrochloride is 290.7. Its structural formula and molecular formula are. Midodrine hydrochloride, USP is an odorless, white, crystalline powder. It is soluble in water and sparingly soluble in methanol and has a pKa of 7.8 (0.3% aqueous solution) and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range of 200° to 203°C. Each midodrine hydrochloride tablet, USP for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43742-1901-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE, PLASTIC (43742-1901-1) </PackageDescription>
<NDC11Code>43742-1901-01</NDC11Code>
<ProductNDC>43742-1901</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Herpes Zoster Nosode</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20210427</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals,Inc.</LabelerName>
<SubstanceName>HUMAN HERPESVIRUS 3</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-10-23</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-APR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70710-1000-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1000-3) </PackageDescription>
<NDC11Code>70710-1000-03</NDC11Code>
<ProductNDC>70710-1000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1001-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1001-3) </PackageDescription>
<NDC11Code>70710-1001-03</NDC11Code>
<ProductNDC>70710-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1002-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70710-1002-3) </PackageDescription>
<NDC11Code>70710-1002-03</NDC11Code>
<ProductNDC>70710-1002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208971</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a calcium-sensing receptor agonist indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet. Its molecular formula is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol, freely soluble in ethanol and practically insoluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3- (trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Each cinacalcet tablet contains 30 mg or 60 mg or 90 mg of cinacalcet (equivalent to 33.060 mg, 66.120 mg, and 99.180 mg of cinacalcet hydrochloride respectively) and inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (botanical source- maize). Additionally film-coating material contains: FD&C blue #1 aluminum lake (90 mg), FD&C blue #2 aluminum lake (60 mg), iron oxide yellow (60mg and 90 mg), polyvinyl alcohol, polyethylene glycols, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1011-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1011-3) </PackageDescription>
<NDC11Code>70710-1011-03</NDC11Code>
<ProductNDC>70710-1011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1012-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) </PackageDescription>
<NDC11Code>70710-1012-03</NDC11Code>
<ProductNDC>70710-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1013-3</NDCCode>
<PackageDescription>30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1013-3) </PackageDescription>
<NDC11Code>70710-1013-03</NDC11Code>
<ProductNDC>70710-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208882</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1). Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. (1.2). Limitations of Use. The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. (1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is. Deferasirox is a white to slightly yellow color powder. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4. Each deferasirox tablets for oral suspension contains deferasirox 125 mg or 250 mg or 500 mg and following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium stearte, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>70710-1014-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70710-1014-3) </PackageDescription>
<NDC11Code>70710-1014-03</NDC11Code>
<ProductNDC>70710-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210189</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>70710-1021-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (70710-1021-3) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1021-03</NDC11Code>
<ProductNDC>70710-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albendazole</ProprietaryName>
<NonProprietaryName>Albendazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208979</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ALBENDAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albendazole tablets are an anthelmintic drug indicated for: 1 Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . (1.1), 2 Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . (1.2).</IndicationAndUsage>
<Description>Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5 - (propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure. Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water. Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1022-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1022-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1022-08</NDC11Code>
<ProductNDC>70710-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1023-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1023-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1023-08</NDC11Code>
<ProductNDC>70710-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1024-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1024-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1024-08</NDC11Code>
<ProductNDC>70710-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1025-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (70710-1025-8) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1025-08</NDC11Code>
<ProductNDC>70710-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1039-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3) </PackageDescription>
<NDC11Code>70710-1039-03</NDC11Code>
<ProductNDC>70710-1039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208949</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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