{
"NDC": [
{
"NDCCode": "0378-0216-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0216-10) ",
"NDC11Code": "00378-0216-10",
"ProductNDC": "0378-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810827",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19810827",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "0378-0216-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0216-01) ",
"NDC11Code": "00378-0216-01",
"ProductNDC": "0378-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810827",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19810827",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "0216-0805-01",
"PackageDescription": "10 mg in 1 VIAL (0216-0805-01)",
"NDC11Code": "00216-0805-01",
"ProductNDC": "0216-0805",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Morphinone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20101103",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "THE UNITED STATES PHARMACOPEIAL CONVENTION",
"SubstanceName": "MORPHINONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0216-2783-01",
"PackageDescription": "10 mg in 1 VIAL (0216-2783-01)",
"NDC11Code": "00216-2783-01",
"ProductNDC": "0216-2783",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zolpidem",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100915",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "THE UNITED STATES PHARMACOPEIAL CONVENTION",
"SubstanceName": "ZOLPIDEM",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0216-9050-01",
"PackageDescription": "10 mg in 1 VIAL (0216-9050-01)",
"NDC11Code": "00216-9050-01",
"ProductNDC": "0216-9050",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydroxycodeinone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20101103",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "THE UNITED STATES PHARMACOPEIAL CONVENTION",
"SubstanceName": "HYDROXYCODEINONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16729-216-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-216-10) ",
"NDC11Code": "16729-0216-10",
"ProductNDC": "16729-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202825",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide."
},
{
"NDCCode": "21695-216-10",
"PackageDescription": "10 mL in 1 BOTTLE, DROPPER (21695-216-10)",
"NDC11Code": "21695-0216-10",
"ProductNDC": "21695-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Antipyrine And Benzocaine",
"NonProprietaryName": "Antipyrine And Benzocaine",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ANTIPYRINE; BENZOCAINE",
"StrengthNumber": "54; 14",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Acute Otitis media of various etiologies. -prompt relief of pain and reduction of inflammation in the congestive and serous stages. -adjuvant therapy during systemic antibiotic administration for resolution of the infection. Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults. Removal of Cerumen. -facilitates the removal of excessive or impacted cerumen.",
"Description": "Antipyrine and Benzocaine Otic Solution is an otic solution containing Antipyrine, Benzocaine, Oxyquinoline Sulfate, and Anhydrous Glycerin for use in the ear. The solution congeals at 0°C (32°F), but returns to normal consistency, unchanged, at room temperature. Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5- one. The active ingredient is represented by the structural formula. Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol. Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate or Benzoic acid, 4-amino-, ethyl ester. The active ingredient is represented by the structural formula. It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents. EACH mL CONTAINS. Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate."
},
{
"NDCCode": "22840-0216-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0216-2) ",
"NDC11Code": "22840-0216-02",
"ProductNDC": "22840-0216",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "K-o-t Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Dactylis Glomerata And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "3333.333; 3333.333; 3333.333",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "29300-216-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10) ",
"NDC11Code": "29300-0216-10",
"ProductNDC": "29300-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207018",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "300; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180331",
"SamplePackage": "N",
"IndicationAndUsage": "Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: 1 In patients not adequately controlled with monotherapy. (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1).",
"Description": "Irbesartan and hydrochlorothiazide tablets, USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan, USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl) benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan, USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: mannitol, croscarmellose sodium, poloxamer 188, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, lecithin, ferric oxide red and ferric oxide yellow."
},
{
"NDCCode": "49288-0216-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0216-3)",
"NDC11Code": "49288-0216-03",
"ProductNDC": "49288-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Grass Smut Mixture",
"NonProprietaryName": "Grass Smut Mixture",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM",
"StrengthNumber": ".01; .01",
"StrengthUnit": "g/mL; g/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. 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%. 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 or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "52054-216-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (52054-216-10)",
"NDC11Code": "52054-0216-10",
"ProductNDC": "52054-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexedrine",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090652",
"LabelerName": "Amedra Pharmaceuticals LLC",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "53489-216-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (53489-216-10)",
"NDC11Code": "53489-0216-10",
"ProductNDC": "53489-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070924",
"LabelerName": "Mutual Pharmaceutical Company, Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride tablets USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "54575-216-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-216-10)",
"NDC11Code": "54575-0216-10",
"ProductNDC": "54575-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phoma Destructiva",
"NonProprietaryName": "Phoma Destructiva",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "PHOMA DESTRUCTIVA",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "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": "54868-0216-0",
"PackageDescription": "1 VIAL in 1 CARTON (54868-0216-0) > 10 mL in 1 VIAL",
"NDC11Code": "54868-0216-00",
"ProductNDC": "54868-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Depo-testosterone",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19940712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085635",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate................................................................................... 100 mg Benzyl benzoate .............................................................................................. 0.1 mL Cottonseed oil ................................................................................................ 736 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg. Each mL of the 200 mg/mL solution contains: Testosterone cypionate .................................................................................. 200 mg Benzyl benzoate .............................................................................................. 0.2 mL Cottonseed oil ................................................................................................ 560 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg."
},
{
"NDCCode": "55154-0216-0",
"PackageDescription": "10 POUCH in 1 BAG (55154-0216-0) > 1 TABLET, FILM COATED in 1 POUCH",
"NDC11Code": "55154-0216-00",
"ProductNDC": "55154-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Conjugated Estrogens",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Cardinal Health",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55312-216-10",
"PackageDescription": "1 BOTTLE in 1 BOX (55312-216-10) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "55312-0216-10",
"ProductNDC": "55312-216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079174",
"LabelerName": "Western Family Foods, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:Headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual crampstemporarily reduces fever."
},
{
"NDCCode": "57687-216-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (57687-216-10) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "57687-0216-10",
"ProductNDC": "57687-216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bach Original Flower Remedies Hornbeam",
"NonProprietaryName": "Carpinus Betulus",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220920",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nelson Bach USA Limited",
"SubstanceName": "CARPINUS BETULUS FLOWERING TOP",
"StrengthNumber": "5",
"StrengthUnit": "[hp_X]/.095mL",
"Status": "Active",
"LastUpdate": "2022-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220920",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of naturally occurring simple nervous tension."
},
{
"NDCCode": "59746-216-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (59746-216-10) ",
"NDC11Code": "59746-0216-10",
"ProductNDC": "59746-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203253",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy 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 (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "63304-216-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (63304-216-10)",
"NDC11Code": "63304-0216-10",
"ProductNDC": "63304-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078722",
"LabelerName": "Ranbaxy Pharmaceuticals Inc",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 5 mg, 7.5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: corn starch, ferric oxide red (for 5 mg tablets), ferric oxide yellow (for 10 mg tablets), FD&C yellow #6 aluminum lake (for 5 mg tablets), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
"NDCCode": "64720-216-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (64720-216-10)",
"NDC11Code": "64720-0216-10",
"ProductNDC": "64720-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090652",
"LabelerName": "CorePharma, LLC",
"SubstanceName": "DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
},
{
"NDCCode": "64950-216-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (64950-216-10) ",
"NDC11Code": "64950-0216-10",
"ProductNDC": "64950-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoniazid",
"NonProprietaryName": "Isoniazid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080936",
"LabelerName": "Genus Lifesciences",
"SubstanceName": "ISONIAZID",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241101",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N",
"IndicationAndUsage": "Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.",
"Description": "Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light."
},
{
"NDCCode": "68382-216-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (68382-216-10) ",
"NDC11Code": "68382-0216-10",
"ProductNDC": "68382-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079017",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170612",
"SamplePackage": "N",
"IndicationAndUsage": "Atomoxetine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Each atomoxetine capsule intended for oral administration contains atomoxetine hydrochloride, USP equivalent to atomoxetine 10 mg or 18 mg or 25 mg or 40 mg or 60 mg or 80 mg or 100 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Additionally each 18 mg capsule shell contains: iron oxide yellow, each 25 mg and 40 mg capsule shell contains: FD & C blue # 2, each 60 mg capsule shell contains: FD & C blue # 2 and iron oxide yellow and each 80 mg and 100 mg capsule shell contains: iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "70860-216-10",
"PackageDescription": "8 VIAL in 1 CARTON (70860-216-10) > 10 mL in 1 VIAL (70860-216-41) ",
"NDC11Code": "70860-0216-10",
"ProductNDC": "70860-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Busulfan",
"NonProprietaryName": "Busulfan",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190210",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205106",
"LabelerName": "Athenex Pharmaceutical Division, LLC.",
"SubstanceName": "BUSULFAN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190210",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0216-1",
"PackageDescription": "10 TABLET in 1 BOTTLE (71335-0216-1) ",
"NDC11Code": "71335-0216-01",
"ProductNDC": "71335-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202677",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160725",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "71919-216-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-216-10) ",
"NDC11Code": "71919-0216-10",
"ProductNDC": "71919-216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coffea Cruda",
"NonProprietaryName": "Arabica Coffee Bean",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "79903-216-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (79903-216-10) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "79903-0216-10",
"ProductNDC": "79903-216",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Aspirin And Caffeine",
"NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211695",
"LabelerName": "WALMART INC.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "treats migraine."
},
{
"NDCCode": "0173-0378-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00173-0378-10",
"ProductNDC": "0173-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortaz",
"NonProprietaryName": "Ceftazidime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041213",
"EndMarketingDate": "20140420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050578",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CEFTAZIDIME SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "0378-0032-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-10) ",
"NDC11Code": "00378-0032-10",
"ProductNDC": "0378-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0047-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) ",
"NDC11Code": "00378-0047-10",
"ProductNDC": "0378-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0078-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0078-10)",
"NDC11Code": "00378-0078-10",
"ProductNDC": "0378-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090324",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0378-0216-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0216-10) </PackageDescription>
<NDC11Code>00378-0216-10</NDC11Code>
<ProductNDC>0378-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810827</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19810827</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0378-0216-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0216-01) </PackageDescription>
<NDC11Code>00378-0216-01</NDC11Code>
<ProductNDC>0378-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810827</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19810827</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0216-0805-01</NDCCode>
<PackageDescription>10 mg in 1 VIAL (0216-0805-01)</PackageDescription>
<NDC11Code>00216-0805-01</NDC11Code>
<ProductNDC>0216-0805</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Morphinone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20101103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>THE UNITED STATES PHARMACOPEIAL CONVENTION</LabelerName>
<SubstanceName>MORPHINONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0216-2783-01</NDCCode>
<PackageDescription>10 mg in 1 VIAL (0216-2783-01)</PackageDescription>
<NDC11Code>00216-2783-01</NDC11Code>
<ProductNDC>0216-2783</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zolpidem</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20100915</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>THE UNITED STATES PHARMACOPEIAL CONVENTION</LabelerName>
<SubstanceName>ZOLPIDEM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0216-9050-01</NDCCode>
<PackageDescription>10 mg in 1 VIAL (0216-9050-01)</PackageDescription>
<NDC11Code>00216-9050-01</NDC11Code>
<ProductNDC>0216-9050</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydroxycodeinone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20101103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>THE UNITED STATES PHARMACOPEIAL CONVENTION</LabelerName>
<SubstanceName>HYDROXYCODEINONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16729-216-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-216-10) </PackageDescription>
<NDC11Code>16729-0216-10</NDC11Code>
<ProductNDC>16729-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202825</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-216-10</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, DROPPER (21695-216-10)</PackageDescription>
<NDC11Code>21695-0216-10</NDC11Code>
<ProductNDC>21695-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Antipyrine And Benzocaine</ProprietaryName>
<NonProprietaryName>Antipyrine And Benzocaine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ANTIPYRINE; BENZOCAINE</SubstanceName>
<StrengthNumber>54; 14</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Acute Otitis media of various etiologies. -prompt relief of pain and reduction of inflammation in the congestive and serous stages. -adjuvant therapy during systemic antibiotic administration for resolution of the infection. Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults. Removal of Cerumen. -facilitates the removal of excessive or impacted cerumen.</IndicationAndUsage>
<Description>Antipyrine and Benzocaine Otic Solution is an otic solution containing Antipyrine, Benzocaine, Oxyquinoline Sulfate, and Anhydrous Glycerin for use in the ear. The solution congeals at 0°C (32°F), but returns to normal consistency, unchanged, at room temperature. Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5- one. The active ingredient is represented by the structural formula. Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol. Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate or Benzoic acid, 4-amino-, ethyl ester. The active ingredient is represented by the structural formula. It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents. EACH mL CONTAINS. Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate.</Description>
</NDC>
<NDC>
<NDCCode>22840-0216-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0216-2) </PackageDescription>
<NDC11Code>22840-0216-02</NDC11Code>
<ProductNDC>22840-0216</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>K-o-t Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Dactylis Glomerata And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>3333.333; 3333.333; 3333.333</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>29300-216-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10) </PackageDescription>
<NDC11Code>29300-0216-10</NDC11Code>
<ProductNDC>29300-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207018</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>IRBESARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>300; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: 1 In patients not adequately controlled with monotherapy. (1), 2 As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1).</IndicationAndUsage>
<Description>Irbesartan and hydrochlorothiazide tablets, USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan, USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl) benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan, USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: mannitol, croscarmellose sodium, poloxamer 188, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, lecithin, ferric oxide red and ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>49288-0216-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0216-3)</PackageDescription>
<NDC11Code>49288-0216-03</NDC11Code>
<ProductNDC>49288-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Grass Smut Mixture</ProprietaryName>
<NonProprietaryName>Grass Smut Mixture</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM</SubstanceName>
<StrengthNumber>.01; .01</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. 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%. 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 or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>52054-216-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (52054-216-10)</PackageDescription>
<NDC11Code>52054-0216-10</NDC11Code>
<ProductNDC>52054-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexedrine</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090652</ApplicationNumber>
<LabelerName>Amedra Pharmaceuticals LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>53489-216-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (53489-216-10)</PackageDescription>
<NDC11Code>53489-0216-10</NDC11Code>
<ProductNDC>53489-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070924</ApplicationNumber>
<LabelerName>Mutual Pharmaceutical Company, Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride tablets USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54575-216-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-216-10)</PackageDescription>
<NDC11Code>54575-0216-10</NDC11Code>
<ProductNDC>54575-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phoma Destructiva</ProprietaryName>
<NonProprietaryName>Phoma Destructiva</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>PHOMA DESTRUCTIVA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>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>54868-0216-0</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (54868-0216-0) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>54868-0216-00</NDC11Code>
<ProductNDC>54868-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Depo-testosterone</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19940712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085635</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate................................................................................... 100 mg Benzyl benzoate .............................................................................................. 0.1 mL Cottonseed oil ................................................................................................ 736 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg. Each mL of the 200 mg/mL solution contains: Testosterone cypionate .................................................................................. 200 mg Benzyl benzoate .............................................................................................. 0.2 mL Cottonseed oil ................................................................................................ 560 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>55154-0216-0</NDCCode>
<PackageDescription>10 POUCH in 1 BAG (55154-0216-0) > 1 TABLET, FILM COATED in 1 POUCH</PackageDescription>
<NDC11Code>55154-0216-00</NDC11Code>
<ProductNDC>55154-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55312-216-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (55312-216-10) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>55312-0216-10</NDC11Code>
<ProductNDC>55312-216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079174</ApplicationNumber>
<LabelerName>Western Family Foods, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:Headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual crampstemporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57687-216-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (57687-216-10) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>57687-0216-10</NDC11Code>
<ProductNDC>57687-216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bach Original Flower Remedies Hornbeam</ProprietaryName>
<NonProprietaryName>Carpinus Betulus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220920</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nelson Bach USA Limited</LabelerName>
<SubstanceName>CARPINUS BETULUS FLOWERING TOP</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_X]/.095mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of naturally occurring simple nervous tension.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59746-216-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (59746-216-10) </PackageDescription>
<NDC11Code>59746-0216-10</NDC11Code>
<ProductNDC>59746-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203253</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy 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 (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63304-216-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (63304-216-10)</PackageDescription>
<NDC11Code>63304-0216-10</NDC11Code>
<ProductNDC>63304-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 5 mg, 7.5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: corn starch, ferric oxide red (for 5 mg tablets), ferric oxide yellow (for 10 mg tablets), FD&C yellow #6 aluminum lake (for 5 mg tablets), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64720-216-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (64720-216-10)</PackageDescription>
<NDC11Code>64720-0216-10</NDC11Code>
<ProductNDC>64720-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090652</ApplicationNumber>
<LabelerName>CorePharma, LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>64950-216-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64950-216-10) </PackageDescription>
<NDC11Code>64950-0216-10</NDC11Code>
<ProductNDC>64950-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoniazid</ProprietaryName>
<NonProprietaryName>Isoniazid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080936</ApplicationNumber>
<LabelerName>Genus Lifesciences</LabelerName>
<SubstanceName>ISONIAZID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.</IndicationAndUsage>
<Description>Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light.</Description>
</NDC>
<NDC>
<NDCCode>68382-216-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (68382-216-10) </PackageDescription>
<NDC11Code>68382-0216-10</NDC11Code>
<ProductNDC>68382-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079017</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atomoxetine is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Each atomoxetine capsule intended for oral administration contains atomoxetine hydrochloride, USP equivalent to atomoxetine 10 mg or 18 mg or 25 mg or 40 mg or 60 mg or 80 mg or 100 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. Additionally each 18 mg capsule shell contains: iron oxide yellow, each 25 mg and 40 mg capsule shell contains: FD & C blue # 2, each 60 mg capsule shell contains: FD & C blue # 2 and iron oxide yellow and each 80 mg and 100 mg capsule shell contains: iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>70860-216-10</NDCCode>
<PackageDescription>8 VIAL in 1 CARTON (70860-216-10) > 10 mL in 1 VIAL (70860-216-41) </PackageDescription>
<NDC11Code>70860-0216-10</NDC11Code>
<ProductNDC>70860-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Busulfan</ProprietaryName>
<NonProprietaryName>Busulfan</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190210</StartMarketingDate>
<EndMarketingDate>20210731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205106</ApplicationNumber>
<LabelerName>Athenex Pharmaceutical Division, LLC.</LabelerName>
<SubstanceName>BUSULFAN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190210</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0216-1</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (71335-0216-1) </PackageDescription>
<NDC11Code>71335-0216-01</NDC11Code>
<ProductNDC>71335-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202677</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride, USP.................................... 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Oxycodone Hydrochloride, USP.................................... 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP.................................................... 325 mg. Inactive Ingredients. All strengths of Oxycodone and Acetaminophen Tablets, USP contain the inactive ingredients crospovidone, lactose monohydrate, povidone, pregelatinized corn starch, and stearic acid. The 5 mg/325 mg tablets contain FD&C Blue No. 1 Aluminum Lake as a colorant. The 7.5 mg/325 mg tablets contain FD&C Yellow No. 6 Aluminum Lake as a colorant. The 10 mg/325 mg tablets contain D&C Yellow No. 10 Aluminum Lake as a colorant. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>71919-216-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-216-10) </PackageDescription>
<NDC11Code>71919-0216-10</NDC11Code>
<ProductNDC>71919-216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coffea Cruda</ProprietaryName>
<NonProprietaryName>Arabica Coffee Bean</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79903-216-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (79903-216-10) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>79903-0216-10</NDC11Code>
<ProductNDC>79903-216</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen Aspirin And Caffeine</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211695</ApplicationNumber>
<LabelerName>WALMART INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats migraine.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0173-0378-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00173-0378-10</NDC11Code>
<ProductNDC>0173-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortaz</ProprietaryName>
<NonProprietaryName>Ceftazidime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041213</StartMarketingDate>
<EndMarketingDate>20140420</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050578</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CEFTAZIDIME SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0032-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-10) </PackageDescription>
<NDC11Code>00378-0032-10</NDC11Code>
<ProductNDC>0378-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0047-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) </PackageDescription>
<NDC11Code>00378-0047-10</NDC11Code>
<ProductNDC>0378-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0078-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0078-10)</PackageDescription>
<NDC11Code>00378-0078-10</NDC11Code>
<ProductNDC>0378-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090324</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
</NDCList>