{
"NDC": [
{
"NDCCode": "0591-0461-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0461-10) ",
"NDC11Code": "00591-0461-10",
"ProductNDC": "0591-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074223",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950227",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid."
},
{
"NDCCode": "0591-0461-00",
"PackageDescription": "24000 TABLET in 1 BAG (0591-0461-00) ",
"NDC11Code": "00591-0461-00",
"ProductNDC": "0591-0461",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"StartMarketingDate": "19950227",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "27-FEB-95"
},
{
"NDCCode": "0591-0461-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0461-01) ",
"NDC11Code": "00591-0461-01",
"ProductNDC": "0591-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074223",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950227",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid."
},
{
"NDCCode": "0591-0461-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (0591-0461-05) ",
"NDC11Code": "00591-0461-05",
"ProductNDC": "0591-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074223",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950227",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid."
},
{
"NDCCode": "0591-0461-77",
"PackageDescription": "28464 TABLET in 1 CONTAINER (0591-0461-77) ",
"NDC11Code": "00591-0461-77",
"ProductNDC": "0591-0461",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"StartMarketingDate": "19950227",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "16-JAN-24"
},
{
"NDCCode": "0363-0461-09",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0363-0461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00363-0461-09",
"ProductNDC": "0363-0461",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu Hbp",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050601",
"EndMarketingDate": "20220305",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 2; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050601",
"EndMarketingDatePackage": "20220305",
"SamplePackage": "N"
},
{
"NDCCode": "0456-0461-63",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-0461-63) / 10 TABLET in 1 BLISTER PACK (0456-0461-11) ",
"NDC11Code": "00456-0461-63",
"ProductNDC": "0456-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armour Thyroid",
"NonProprietaryName": "Thyroid, Porcine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "SUS SCROFA THYROID",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19960401",
"SamplePackage": "N",
"IndicationAndUsage": "Armour Thyroid (thyroid tablets, USP) are indicated. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.",
"Description": "Armour Thyroid (thyroid tablets, USP)* for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white. Armour Thyroid may have a strong, characteristic odor due to its thyroid extract component."
},
{
"NDCCode": "12658-0461-1",
"PackageDescription": "10 kg in 1 DRUM (12658-0461-1)",
"NDC11Code": "12658-0461-01",
"ProductNDC": "12658-0461",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "POWDER",
"StartMarketingDate": "19820101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZAKLADY FARMACEUTYCZNE POLPHARMA S A",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "10",
"StrengthUnit": "kg/10kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "25021-461-10",
"PackageDescription": "1 VIAL in 1 CARTON (25021-461-10) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0461-10",
"ProductNDC": "25021-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204751",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "ug/10mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "Desmopressin Acetate Injection is a vasopressin analog used for: : 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1) , 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2) , 3 von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3) .",
"Description": "Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Acetate Injection, USP is a sterile solution in a 10 mL multi-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "45963-461-10",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-461-10) ",
"NDC11Code": "45963-0461-10",
"ProductNDC": "45963-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130118",
"EndMarketingDate": "20181231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "ACTAVIS PHARMA, INC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130118",
"EndMarketingDatePackage": "20181031",
"SamplePackage": "N"
},
{
"NDCCode": "46708-461-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 CARTON (46708-461-10) ",
"NDC11Code": "46708-0461-10",
"ProductNDC": "46708-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "10; 320",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and valsartan tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure: : 1 In patients not adequately controlled on monotherapy (1) , 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1) .",
"Description": "Amlodipine and valsartan tablets, USP are fixed combination of amlodipine and valsartan.Amlodipine and valsartan tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is white or almost white hygroscopic powder, freely soluble in anhydrous ethanol; sparingly soluble in methylene chloride; practically insoluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets, USP are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Additionally the 5/160 mg and 5/320 mg strengths contain iron oxide red. The film coating contains hypromellose, iron oxide yellow, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "49288-0461-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0461-3)",
"NDC11Code": "49288-0461-03",
"ProductNDC": "49288-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Miller Moth",
"NonProprietaryName": "Miller Moth",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "SITOTROGA CEREALELLA",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "50228-461-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-10) ",
"NDC11Code": "50228-0461-10",
"ProductNDC": "50228-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214091",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "50; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211005",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, hypromellose and also contain FD&C Blue #2. The 25 mg/100 mg tablet is supplied as a light blue, mottled, oval, uncoated tablets debossed with 'SG' on one side and '460' on the other side. The 50 mg/200 mg tablet is supplied as a light blue, mottled, oval, uncoated tablets debossed with 'SG' on one side and '461' on the other side. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "52685-461-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (52685-461-10) > 126.5 g in 1 BOTTLE",
"NDC11Code": "52685-0461-10",
"ProductNDC": "52685-461",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Gentle Protective I",
"NonProprietaryName": "Avobenzone, Octinoxate, Octocrylene, And Oxybenzone",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO CO., LTD.",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3163; 9361; 2530; 1265",
"StrengthUnit": "mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54575-461-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-461-10)",
"NDC11Code": "54575-0461-10",
"ProductNDC": "54575-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yellow Squash",
"NonProprietaryName": "Squash",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "SQUASH",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "67253-461-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (67253-461-10)",
"NDC11Code": "67253-0461-10",
"ProductNDC": "67253-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19971222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074591",
"LabelerName": "DAVA Pharmaceuticals, Inc.",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "68083-461-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01) ",
"NDC11Code": "68083-0461-10",
"ProductNDC": "68083-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosphenytoin Sodium",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214926",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
"Description": "Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
},
{
"NDCCode": "68462-461-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10) ",
"NDC11Code": "68462-0461-10",
"ProductNDC": "68462-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trospium Chloride",
"NonProprietaryName": "Trospium Chloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091575",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TROSPIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230630",
"SamplePackage": "N",
"IndicationAndUsage": "Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Trospium chloride, USP is a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1R, 3r, 5S). The empirical formula of trospium chloride, USP is C25H30ClNO3 and its molecular weight is 427.96 g/mol. The structural formula of trospium chloride, USP is represented below. Trospium chloride, USP is a white or almost white, crystalline powder. It is very soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. Each Trospium Chloride Tablet, USP contains 20 mg of trospium chloride, USP, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, polyethylene glycol 400, hypromellose, yellow iron oxide and red iron oxide."
},
{
"NDCCode": "71919-461-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-461-10) ",
"NDC11Code": "71919-0461-10",
"ProductNDC": "71919-461",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Solubilis",
"NonProprietaryName": "Mercurius Solubilis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MERCURIUS SOLUBILIS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "72843-461-10",
"PackageDescription": "10 VIAL in 1 CARTON (72843-461-10) / 1 mL in 1 VIAL",
"NDC11Code": "72843-0461-10",
"ProductNDC": "72843-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20200917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210223",
"LabelerName": "UBI Pharma Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200917",
"SamplePackage": "N",
"Description": "Desmopressin Acetate Injection USP (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1129.27 Empirical Formula: C 46H 64N 14O 12S 2C 2H 4O 2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin Acetate solution for injection is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin Acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH."
},
{
"NDCCode": "0591-0149-87",
"PackageDescription": "10 VIAL in 1 CARTON (0591-0149-87) > 5 mL in 1 VIAL (0591-0149-26) ",
"NDC11Code": "00591-0149-87",
"ProductNDC": "0591-0149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Ferric Gluconate Complex",
"NonProprietaryName": "Sodium Ferric Gluconate Complex",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110331",
"EndMarketingDate": "20190630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078215",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "SODIUM FERRIC GLUCONATE COMPLEX",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110331",
"EndMarketingDatePackage": "20190630",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0240-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0240-10) ",
"NDC11Code": "00591-0240-10",
"ProductNDC": "0591-0240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072926",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911031",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0241-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0241-10) ",
"NDC11Code": "00591-0241-10",
"ProductNDC": "0591-0241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072927",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911031",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0242-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0242-10) ",
"NDC11Code": "00591-0242-10",
"ProductNDC": "0591-0242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19911031",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072928",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911031",
"EndMarketingDatePackage": "20221130",
"SamplePackage": "N"
},
{
"NDCCode": "0591-0338-10",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 BOX (0591-0338-10) > 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "00591-0338-10",
"ProductNDC": "0591-0338",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981113",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0591-0339-10",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 BOX (0591-0339-10) > 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "00591-0339-10",
"ProductNDC": "0591-0339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981113",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0591-0343-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-10) ",
"NDC11Code": "00591-0343-10",
"ProductNDC": "0591-0343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19861001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070995",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19861001",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white)."
},
{
"NDCCode": "0591-0345-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0345-10) ",
"NDC11Code": "00591-0345-10",
"ProductNDC": "0591-0345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19861001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070994",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19861001",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil hydrochloride, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white)."
},
{
"NDCCode": "0591-0348-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10) ",
"NDC11Code": "00591-0348-10",
"ProductNDC": "0591-0348",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071851",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930923",
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"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone., 2 Triamterene and hydrochlorothiazide tablets are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).",
"Description": "Triamterene and hydrochlorothiazide tablets, USP combine triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet USP, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothiazide tablet USP, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No. 2 Aluminum Lake. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is. C12H11N7. Triamterene, USP. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is. C7H8ClN3O4S2. Hydrochlorothiazide, USP."
},
{
"NDCCode": "0591-0406-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0406-10) ",
"NDC11Code": "00591-0406-10",
"ProductNDC": "0591-0406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076059",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020701",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 (tartrazine) Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch."
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074223</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
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<NDC>
<NDCCode>0591-0461-00</NDCCode>
<PackageDescription>24000 TABLET in 1 BAG (0591-0461-00) </PackageDescription>
<NDC11Code>00591-0461-00</NDC11Code>
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<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-FEB-95</StartMarketingDatePackage>
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<NDC>
<NDCCode>0591-0461-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0461-01) </PackageDescription>
<NDC11Code>00591-0461-01</NDC11Code>
<ProductNDC>0591-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074223</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0591-0461-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (0591-0461-05) </PackageDescription>
<NDC11Code>00591-0461-05</NDC11Code>
<ProductNDC>0591-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074223</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0591-0461-77</NDCCode>
<PackageDescription>28464 TABLET in 1 CONTAINER (0591-0461-77) </PackageDescription>
<NDC11Code>00591-0461-77</NDC11Code>
<ProductNDC>0591-0461</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>19950227</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-18</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0363-0461-09</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0363-0461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-0461-09</NDC11Code>
<ProductNDC>0363-0461</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu Hbp</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050601</StartMarketingDate>
<EndMarketingDate>20220305</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>500; 2; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050601</StartMarketingDatePackage>
<EndMarketingDatePackage>20220305</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0456-0461-63</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-0461-63) / 10 TABLET in 1 BLISTER PACK (0456-0461-11) </PackageDescription>
<NDC11Code>00456-0461-63</NDC11Code>
<ProductNDC>0456-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armour Thyroid</ProprietaryName>
<NonProprietaryName>Thyroid, Porcine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>SUS SCROFA THYROID</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armour Thyroid (thyroid tablets, USP) are indicated. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
<Description>Armour Thyroid (thyroid tablets, USP)* for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white. Armour Thyroid may have a strong, characteristic odor due to its thyroid extract component.</Description>
</NDC>
<NDC>
<NDCCode>12658-0461-1</NDCCode>
<PackageDescription>10 kg in 1 DRUM (12658-0461-1)</PackageDescription>
<NDC11Code>12658-0461-01</NDC11Code>
<ProductNDC>12658-0461</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19820101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZAKLADY FARMACEUTYCZNE POLPHARMA S A</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>kg/10kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>25021-461-10</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-461-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0461-10</NDC11Code>
<ProductNDC>25021-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204751</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/10mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desmopressin Acetate Injection is a vasopressin analog used for: : 1 Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1) , 2 Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2) , 3 von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3) .</IndicationAndUsage>
<Description>Desmopressin Acetate Injection, USP is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows:. Mol. Wt. 1183.34. Empirical Formula: C46H64N14O12S2C2H4O23H2O. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin Acetate Injection, USP is a sterile solution in a 10 mL multi-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>45963-461-10</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-461-10) </PackageDescription>
<NDC11Code>45963-0461-10</NDC11Code>
<ProductNDC>45963-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<EndMarketingDate>20181231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>ACTAVIS PHARMA, INC.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130118</StartMarketingDatePackage>
<EndMarketingDatePackage>20181031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-461-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 CARTON (46708-461-10) </PackageDescription>
<NDC11Code>46708-0461-10</NDC11Code>
<ProductNDC>46708-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 320</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and valsartan tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure: : 1 In patients not adequately controlled on monotherapy (1) , 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1) .</IndicationAndUsage>
<Description>Amlodipine and valsartan tablets, USP are fixed combination of amlodipine and valsartan.Amlodipine and valsartan tablets, USP contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is. Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is white or almost white hygroscopic powder, freely soluble in anhydrous ethanol; sparingly soluble in methylene chloride; practically insoluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is. Its empirical formula is C24H29N5O3 and its molecular weight is 435.5. Amlodipine and valsartan tablets, USP are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Additionally the 5/160 mg and 5/320 mg strengths contain iron oxide red. The film coating contains hypromellose, iron oxide yellow, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49288-0461-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0461-3)</PackageDescription>
<NDC11Code>49288-0461-03</NDC11Code>
<ProductNDC>49288-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Miller Moth</ProprietaryName>
<NonProprietaryName>Miller Moth</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>SITOTROGA CEREALELLA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>50228-461-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-461-10) </PackageDescription>
<NDC11Code>50228-0461-10</NDC11Code>
<ProductNDC>50228-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214091</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10H 14N 2O 4H 2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9H 11NO 4, and its structural formula is:. Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, hypromellose and also contain FD&C Blue #2. The 25 mg/100 mg tablet is supplied as a light blue, mottled, oval, uncoated tablets debossed with 'SG' on one side and '460' on the other side. The 50 mg/200 mg tablet is supplied as a light blue, mottled, oval, uncoated tablets debossed with 'SG' on one side and '461' on the other side. Carbidopa and levodopa extended-release tablets, USP are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>52685-461-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52685-461-10) > 126.5 g in 1 BOTTLE</PackageDescription>
<NDC11Code>52685-0461-10</NDC11Code>
<ProductNDC>52685-461</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Gentle Protective I</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO CO., LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3163; 9361; 2530; 1265</StrengthNumber>
<StrengthUnit>mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54575-461-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-461-10)</PackageDescription>
<NDC11Code>54575-0461-10</NDC11Code>
<ProductNDC>54575-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yellow Squash</ProprietaryName>
<NonProprietaryName>Squash</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>SQUASH</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>67253-461-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (67253-461-10)</PackageDescription>
<NDC11Code>67253-0461-10</NDC11Code>
<ProductNDC>67253-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074591</ApplicationNumber>
<LabelerName>DAVA Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>68083-461-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01) </PackageDescription>
<NDC11Code>68083-0461-10</NDC11Code>
<ProductNDC>68083-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214926</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin. Fosphenytoin sodium injection should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
</NDC>
<NDC>
<NDCCode>68462-461-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10) </PackageDescription>
<NDC11Code>68462-0461-10</NDC11Code>
<ProductNDC>68462-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trospium Chloride</ProprietaryName>
<NonProprietaryName>Trospium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091575</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TROSPIUM CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Trospium chloride, USP is a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1R, 3r, 5S). The empirical formula of trospium chloride, USP is C25H30ClNO3 and its molecular weight is 427.96 g/mol. The structural formula of trospium chloride, USP is represented below. Trospium chloride, USP is a white or almost white, crystalline powder. It is very soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. Each Trospium Chloride Tablet, USP contains 20 mg of trospium chloride, USP, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, polyethylene glycol 400, hypromellose, yellow iron oxide and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71919-461-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-461-10) </PackageDescription>
<NDC11Code>71919-0461-10</NDC11Code>
<ProductNDC>71919-461</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Solubilis</ProprietaryName>
<NonProprietaryName>Mercurius Solubilis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MERCURIUS SOLUBILIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72843-461-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (72843-461-10) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>72843-0461-10</NDC11Code>
<ProductNDC>72843-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desmopressin Acetate</ProprietaryName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210223</ApplicationNumber>
<LabelerName>UBI Pharma Inc.</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Desmopressin Acetate Injection USP (desmopressin acetate) is a synthetic vasopressin analog for intravenous or subcutaneous use. It is chemically defined as follows. Mol. Wt. 1129.27 Empirical Formula: C 46H 64N 14O 12S 2C 2H 4O 2. 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin Acetate solution for injection is a sterile solution in a 1 mL single-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH. Desmopressin Acetate solution for injection is a sterile solution in a 10 mL multiple-dose vial: Each mL contains 4 mcg of desmopressin acetate which is equivalent to 3.6 mcg of desmopressin free base. The inactive ingredients are sodium chloride, chlorobutanol (5 mg per mL), hydrochloric acid and water for injection. Sodium chloride is used to adjust tonicity. Hydrochloric acid is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0591-0149-87</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0591-0149-87) > 5 mL in 1 VIAL (0591-0149-26) </PackageDescription>
<NDC11Code>00591-0149-87</NDC11Code>
<ProductNDC>0591-0149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Ferric Gluconate Complex</ProprietaryName>
<NonProprietaryName>Sodium Ferric Gluconate Complex</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110331</StartMarketingDate>
<EndMarketingDate>20190630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078215</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>SODIUM FERRIC GLUCONATE COMPLEX</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110331</StartMarketingDatePackage>
<EndMarketingDatePackage>20190630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0240-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0591-0240-10) </PackageDescription>
<NDC11Code>00591-0240-10</NDC11Code>
<ProductNDC>0591-0240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072926</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911031</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0241-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0591-0241-10) </PackageDescription>
<NDC11Code>00591-0241-10</NDC11Code>
<ProductNDC>0591-0241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072927</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911031</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0242-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0591-0242-10) </PackageDescription>
<NDC11Code>00591-0242-10</NDC11Code>
<ProductNDC>0591-0242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911031</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072928</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911031</StartMarketingDatePackage>
<EndMarketingDatePackage>20221130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-0338-10</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 BOX (0591-0338-10) > 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00591-0338-10</NDC11Code>
<ProductNDC>0591-0338</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981113</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>Watson Pharma, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0339-10</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 BOX (0591-0339-10) > 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00591-0339-10</NDC11Code>
<ProductNDC>0591-0339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981113</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>Watson Pharma, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0591-0343-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-10) </PackageDescription>
<NDC11Code>00591-0343-10</NDC11Code>
<ProductNDC>0591-0343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070995</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white).</Description>
</NDC>
<NDC>
<NDCCode>0591-0345-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0345-10) </PackageDescription>
<NDC11Code>00591-0345-10</NDC11Code>
<ProductNDC>0591-0345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070994</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Tablets are indicated for the treatment of the following. Angina1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina). Arrhythmias1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia. Essential hypertension:Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil hydrochloride, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg, or 120 mg of verapamil hydrochloride, USP. The structural formula of verapamil hydrochloride, USP is. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride, USP is not chemically related to other cardioactive drugs. Inactive ingredients include anhydrous lactose, corn starch, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and polyethylene glycol 400. In addition the following coloring agents are used: FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose and titanium dioxide (40 mg light peach); hydroxypropyl cellulose and titanium dioxide (80 mg white and 120 mg white).</Description>
</NDC>
<NDC>
<NDCCode>0591-0348-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0591-0348-10) </PackageDescription>
<NDC11Code>00591-0348-10</NDC11Code>
<ProductNDC>0591-0348</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071851</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone., 2 Triamterene and hydrochlorothiazide tablets are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide tablets, USP combine triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet USP, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothiazide tablet USP, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No. 2 Aluminum Lake. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is. C12H11N7. Triamterene, USP. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is. C7H8ClN3O4S2. Hydrochlorothiazide, USP.</Description>
</NDC>
<NDC>
<NDCCode>0591-0406-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0591-0406-10) </PackageDescription>
<NDC11Code>00591-0406-10</NDC11Code>
<ProductNDC>0591-0406</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076059</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 (tartrazine) Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch.</Description>
</NDC>
</NDCList>