{
"NDC": [
{
"NDCCode": "51552-0826-4",
"PackageDescription": "25 g in 1 CONTAINER (51552-0826-4) ",
"NDC11Code": "51552-0826-04",
"ProductNDC": "51552-0826",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betahistine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "BETAHISTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "30-APR-26"
},
{
"NDCCode": "51552-0826-2",
"PackageDescription": "5 g in 1 CONTAINER (51552-0826-2) ",
"NDC11Code": "51552-0826-02",
"ProductNDC": "51552-0826",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betahistine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "BETAHISTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "30-APR-26"
},
{
"NDCCode": "51552-0826-3",
"PackageDescription": "10 g in 1 CONTAINER (51552-0826-3) ",
"NDC11Code": "51552-0826-03",
"ProductNDC": "51552-0826",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betahistine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "BETAHISTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "31-OCT-24"
},
{
"NDCCode": "51552-0826-5",
"PackageDescription": "100 g in 1 CONTAINER (51552-0826-5) ",
"NDC11Code": "51552-0826-05",
"ProductNDC": "51552-0826",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Betahistine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "BETAHISTINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "31-AUG-25"
},
{
"NDCCode": "17856-0826-4",
"PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-4) / 1 mL in 1 SYRINGE",
"NDC11Code": "17856-0826-04",
"ProductNDC": "17856-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206822",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol."
},
{
"NDCCode": "65044-0826-4",
"PackageDescription": "50 mL in 1 VIAL (65044-0826-4) ",
"NDC11Code": "65044-0826-04",
"ProductNDC": "65044-0826",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
"NonProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103878",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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": "71335-0826-4",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-0826-4) ",
"NDC11Code": "71335-0826-04",
"ProductNDC": "71335-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220128",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "79481-0826-4",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (79481-0826-4) ",
"NDC11Code": "79481-0826-04",
"ProductNDC": "79481-0826",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Meijer, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommended for repeated use."
},
{
"NDCCode": "0054-0826-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-0826-13) ",
"NDC11Code": "00054-0826-13",
"ProductNDC": "0054-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20261007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220524",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261007",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C25H31NO6. The chemical name for deflazacort is 16α,17-isoxazole-11β,21-dihydroxypregna-1,4-diene-3,20-dione 21acetate, and the structure is:. Deflazacort is a white to off white, odorless fine powder and has a molecular weight of 441.52. Deflazacort is freely soluble in acetic acid and dichloromethane and soluble in methanol and acetone. Deflazacort tablets for oral administration are available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pre-gelatinized corn starch."
},
{
"NDCCode": "10135-826-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-10) ",
"NDC11Code": "10135-0826-10",
"ProductNDC": "10135-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "10135-826-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-30) ",
"NDC11Code": "10135-0826-30",
"ProductNDC": "10135-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "10135-826-75",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-75) ",
"NDC11Code": "10135-0826-75",
"ProductNDC": "10135-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "10135-826-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-90) ",
"NDC11Code": "10135-0826-90",
"ProductNDC": "10135-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201272",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "10356-826-25",
"PackageDescription": "4.8 g in 1 TUBE (10356-826-25)",
"NDC11Code": "10356-0826-25",
"ProductNDC": "10356-826",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nivea A Kiss Of Strawberry Fruity Lip Care",
"NonProprietaryName": "Avobenzone, Octinoxate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110125",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "AVOBENZONE; OCTINOXATE",
"StrengthNumber": ".01; .03",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "13537-826-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-826-02) > 4 g in 1 TUBE (13537-826-01)",
"NDC11Code": "13537-0826-02",
"ProductNDC": "13537-826",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(rosa Encanto Femme) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "17856-0826-1",
"PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-1) / .5 mL in 1 SYRINGE",
"NDC11Code": "17856-0826-01",
"ProductNDC": "17856-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206822",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol."
},
{
"NDCCode": "17856-0826-2",
"PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-2) / .125 mL in 1 SYRINGE",
"NDC11Code": "17856-0826-02",
"ProductNDC": "17856-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206822",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol."
},
{
"NDCCode": "17856-0826-3",
"PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-3) / 1 mL in 1 SYRINGE",
"NDC11Code": "17856-0826-03",
"ProductNDC": "17856-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206822",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol."
},
{
"NDCCode": "17856-0826-5",
"PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-5) / .25 mL in 1 SYRINGE",
"NDC11Code": "17856-0826-05",
"ProductNDC": "17856-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206822",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol."
},
{
"NDCCode": "17856-0826-6",
"PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-6) / .25 mL in 1 SYRINGE",
"NDC11Code": "17856-0826-06",
"ProductNDC": "17856-0826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206822",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol."
},
{
"NDCCode": "25021-826-67",
"PackageDescription": "1 BAG in 1 CARTON (25021-826-67) > 100 mL in 1 BAG",
"NDC11Code": "25021-0826-67",
"ProductNDC": "25021-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203231",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": ".04",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2022-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150901",
"SamplePackage": "N",
"IndicationAndUsage": "Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .",
"Description": "Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5."
},
{
"NDCCode": "25021-826-82",
"PackageDescription": "1 BAG in 1 CARTON (25021-826-82) / 100 mL in 1 BAG",
"NDC11Code": "25021-0826-82",
"ProductNDC": "25021-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130302",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203231",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": ".04",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130302",
"SamplePackage": "N",
"IndicationAndUsage": "Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .",
"Description": "Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5."
},
{
"NDCCode": "25021-826-87",
"PackageDescription": "5 BAG in 1 CARTON (25021-826-87) / 100 mL in 1 BAG",
"NDC11Code": "25021-0826-87",
"ProductNDC": "25021-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130302",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203231",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": ".04",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"IndicationAndUsage": "Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .",
"Description": "Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5."
},
{
"NDCCode": "33261-826-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-826-30)",
"NDC11Code": "33261-0826-30",
"ProductNDC": "33261-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077995",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1), 2 Coronary Artery Disease (1.2), 3 Chronic Stable Angina, 4 Vasospastic Angina (Prinzmetal’s or Variant Angina), 5 Angiographically Documented Coronary Artery, 6 Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "33261-826-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (33261-826-60)",
"NDC11Code": "33261-0826-60",
"ProductNDC": "33261-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077995",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1), 2 Coronary Artery Disease (1.2), 3 Chronic Stable Angina, 4 Vasospastic Angina (Prinzmetal’s or Variant Angina), 5 Angiographically Documented Coronary Artery, 6 Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "33261-826-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (33261-826-90)",
"NDC11Code": "33261-0826-90",
"ProductNDC": "33261-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077995",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1), 2 Coronary Artery Disease (1.2), 3 Chronic Stable Angina, 4 Vasospastic Angina (Prinzmetal’s or Variant Angina), 5 Angiographically Documented Coronary Artery, 6 Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "36800-826-50",
"PackageDescription": "50 LOZENGE in 1 BAG (36800-826-50) ",
"NDC11Code": "36800-0826-50",
"ProductNDC": "36800-826",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Herbal Cough Drops",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20160525",
"EndMarketingDate": "20190801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Topco Associates",
"SubstanceName": "MENTHOL",
"StrengthNumber": "4.8",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160525",
"EndMarketingDatePackage": "20190801",
"SamplePackage": "N"
},
{
"NDCCode": "42291-826-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42291-826-30) ",
"NDC11Code": "42291-0826-30",
"ProductNDC": "42291-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209057",
"LabelerName": "AvKARE",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with \"2.5\", \"5\", \"10\" or \"20\" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, aspartame, titanium dioxide, ferric oxide red, and ferric oxide yellow."
},
{
"NDCCode": "43353-826-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-15) ",
"NDC11Code": "43353-0826-15",
"ProductNDC": "43353-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020702",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130311",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "43353-826-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-30) ",
"NDC11Code": "43353-0826-30",
"ProductNDC": "43353-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020702",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130311",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
}
]
}
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<NDCList>
<NDC>
<NDCCode>51552-0826-4</NDCCode>
<PackageDescription>25 g in 1 CONTAINER (51552-0826-4) </PackageDescription>
<NDC11Code>51552-0826-04</NDC11Code>
<ProductNDC>51552-0826</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betahistine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>BETAHISTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>30-APR-26</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0826-2</NDCCode>
<PackageDescription>5 g in 1 CONTAINER (51552-0826-2) </PackageDescription>
<NDC11Code>51552-0826-02</NDC11Code>
<ProductNDC>51552-0826</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betahistine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>BETAHISTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>30-APR-26</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0826-3</NDCCode>
<PackageDescription>10 g in 1 CONTAINER (51552-0826-3) </PackageDescription>
<NDC11Code>51552-0826-03</NDC11Code>
<ProductNDC>51552-0826</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betahistine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>BETAHISTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>31-OCT-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0826-5</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (51552-0826-5) </PackageDescription>
<NDC11Code>51552-0826-05</NDC11Code>
<ProductNDC>51552-0826</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Betahistine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>BETAHISTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>31-AUG-25</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>17856-0826-4</NDCCode>
<PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-4) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0826-04</NDC11Code>
<ProductNDC>17856-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206822</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>65044-0826-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL (65044-0826-4) </PackageDescription>
<NDC11Code>65044-0826-04</NDC11Code>
<ProductNDC>65044-0826</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103878</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 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>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and 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) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen 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.2, 4, 5, 6 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>71335-0826-4</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-0826-4) </PackageDescription>
<NDC11Code>71335-0826-04</NDC11Code>
<ProductNDC>71335-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>79481-0826-4</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (79481-0826-4) </PackageDescription>
<NDC11Code>79481-0826-04</NDC11Code>
<ProductNDC>79481-0826</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Meijer, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0054-0826-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0054-0826-13) </PackageDescription>
<NDC11Code>00054-0826-13</NDC11Code>
<ProductNDC>0054-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220524</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C25H31NO6. The chemical name for deflazacort is 16α,17-isoxazole-11β,21-dihydroxypregna-1,4-diene-3,20-dione 21acetate, and the structure is:. Deflazacort is a white to off white, odorless fine powder and has a molecular weight of 441.52. Deflazacort is freely soluble in acetic acid and dichloromethane and soluble in methanol and acetone. Deflazacort tablets for oral administration are available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pre-gelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>10135-826-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-10) </PackageDescription>
<NDC11Code>10135-0826-10</NDC11Code>
<ProductNDC>10135-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10135-826-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-30) </PackageDescription>
<NDC11Code>10135-0826-30</NDC11Code>
<ProductNDC>10135-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10135-826-75</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-75) </PackageDescription>
<NDC11Code>10135-0826-75</NDC11Code>
<ProductNDC>10135-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10135-826-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-826-90) </PackageDescription>
<NDC11Code>10135-0826-90</NDC11Code>
<ProductNDC>10135-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201272</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 anic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres, colloidal silicon dioxide, ethylcellulose, hypromellose, triethyl citrate, talc, polyethylene glycol, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the capsule of the 37.5 mg strength contains iron oxide yellow, iron oxide red and iron oxide black; the capsule of the 75 mg strength contains iron oxide yellow and iron oxide red; the capsule of the 150 mg strength contains D&C Yellow #10, FD&C Blue #1, and FD&C Red #40. The imprinting ink for all strengths’ capsules contains shellac, iron oxide black, propylene glycol, ammonia solution, and potassium hydroxide. Venlafaxine hydrochloride extended-release capsules, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>10356-826-25</NDCCode>
<PackageDescription>4.8 g in 1 TUBE (10356-826-25)</PackageDescription>
<NDC11Code>10356-0826-25</NDC11Code>
<ProductNDC>10356-826</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nivea A Kiss Of Strawberry Fruity Lip Care</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>.01; .03</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>13537-826-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-826-02) > 4 g in 1 TUBE (13537-826-01)</PackageDescription>
<NDC11Code>13537-0826-02</NDC11Code>
<ProductNDC>13537-826</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(rosa Encanto Femme) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0826-1</NDCCode>
<PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-1) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0826-01</NDC11Code>
<ProductNDC>17856-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206822</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>17856-0826-2</NDCCode>
<PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-2) / .125 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0826-02</NDC11Code>
<ProductNDC>17856-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206822</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>17856-0826-3</NDCCode>
<PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-3) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0826-03</NDC11Code>
<ProductNDC>17856-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206822</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>17856-0826-5</NDCCode>
<PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-5) / .25 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0826-05</NDC11Code>
<ProductNDC>17856-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206822</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>17856-0826-6</NDCCode>
<PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0826-6) / .25 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0826-06</NDC11Code>
<ProductNDC>17856-0826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206822</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: artificial raspberry flavor, citric acid, D&C Yellow #10, purified water, saccharin sodium, sodium benzoate, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>25021-826-67</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (25021-826-67) > 100 mL in 1 BAG</PackageDescription>
<NDC11Code>25021-0826-67</NDC11Code>
<ProductNDC>25021-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203231</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .</IndicationAndUsage>
<Description>Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>25021-826-82</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (25021-826-82) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>25021-0826-82</NDC11Code>
<ProductNDC>25021-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130302</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203231</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .</IndicationAndUsage>
<Description>Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>25021-826-87</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (25021-826-87) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>25021-0826-87</NDC11Code>
<ProductNDC>25021-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130302</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203231</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .</IndicationAndUsage>
<Description>Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is as following:. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in bags as a sterile liquid solution for intravenous infusion. Each 100 mL bag contains 4.264 mg of zoledronic acid monohydrate (equivalent to 4 mg zoledronic acid on an anhydrous basis), 900 mg of sodium chloride, USP, 220 mg of mannitol, USP, water for injection q.s. and 24 mg of sodium citrate to adjust pH. The pH of the solution is approximately 5.5 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>33261-826-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-826-30)</PackageDescription>
<NDC11Code>33261-0826-30</NDC11Code>
<ProductNDC>33261-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077995</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1), 2 Coronary Artery Disease (1.2), 3 Chronic Stable Angina, 4 Vasospastic Angina (Prinzmetal’s or Variant Angina), 5 Angiographically Documented Coronary Artery, 6 Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33261-826-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (33261-826-60)</PackageDescription>
<NDC11Code>33261-0826-60</NDC11Code>
<ProductNDC>33261-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077995</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1), 2 Coronary Artery Disease (1.2), 3 Chronic Stable Angina, 4 Vasospastic Angina (Prinzmetal’s or Variant Angina), 5 Angiographically Documented Coronary Artery, 6 Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33261-826-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (33261-826-90)</PackageDescription>
<NDC11Code>33261-0826-90</NDC11Code>
<ProductNDC>33261-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077995</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: 1 Hypertension (1.1), 2 Coronary Artery Disease (1.2), 3 Chronic Stable Angina, 4 Vasospastic Angina (Prinzmetal’s or Variant Angina), 5 Angiographically Documented Coronary Artery, 6 Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5 C6H6O3S, and its structural formula is. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>36800-826-50</NDCCode>
<PackageDescription>50 LOZENGE in 1 BAG (36800-826-50) </PackageDescription>
<NDC11Code>36800-0826-50</NDC11Code>
<ProductNDC>36800-826</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Herbal Cough Drops</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160525</StartMarketingDate>
<EndMarketingDate>20190801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Topco Associates</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>4.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160525</StartMarketingDatePackage>
<EndMarketingDatePackage>20190801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-826-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42291-826-30) </PackageDescription>
<NDC11Code>42291-0826-30</NDC11Code>
<ProductNDC>42291-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209057</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, aspartame, titanium dioxide, ferric oxide red, and ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>43353-826-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-15) </PackageDescription>
<NDC11Code>43353-0826-15</NDC11Code>
<ProductNDC>43353-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
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<NDCCode>43353-826-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-826-30) </PackageDescription>
<NDC11Code>43353-0826-30</NDC11Code>
<ProductNDC>43353-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
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