{
"NDC": [
{
"NDCCode": "59762-3070-2",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (59762-3070-2) ",
"NDC11Code": "59762-3070-02",
"ProductNDC": "59762-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020524",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050784",
"LabelerName": "Greenstone LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20020524",
"SamplePackage": "N"
},
{
"NDCCode": "59762-3070-1",
"PackageDescription": "3 BLISTER PACK in 1 BOX (59762-3070-1) > 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59762-3070-01",
"ProductNDC": "59762-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020524",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050784",
"LabelerName": "Greenstone LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20020524",
"SamplePackage": "N"
},
{
"NDCCode": "10742-3070-1",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10742-3070-1) / 4.2 g in 1 TUBE",
"NDC11Code": "10742-3070-01",
"ProductNDC": "10742-3070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mentholatum Natural Ice - Original, Spf 15",
"ProprietaryNameSuffix": "Original",
"NonProprietaryName": "Dimethicone, Octinoxate, Octisalate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Mentholatum Company",
"SubstanceName": "OCTISALATE; DIMETHICONE; OCTINOXATE",
"StrengthNumber": "50; 10; 75",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "36987-3070-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3070-2)",
"NDC11Code": "36987-3070-02",
"ProductNDC": "36987-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "California Black Walnut",
"NonProprietaryName": "California Black Walnut",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "JUGLANS CALIFORNICA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3070-2",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-3070-2) ",
"NDC11Code": "37662-3070-02",
"ProductNDC": "37662-3070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Strontium Metallicum",
"NonProprietaryName": "Strontium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STRONTIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230428",
"SamplePackage": "N"
},
{
"NDCCode": "54569-3070-2",
"PackageDescription": "98 TABLET, FILM COATED in 1 BOTTLE (54569-3070-2)",
"NDC11Code": "54569-3070-02",
"ProductNDC": "54569-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Myambutol",
"NonProprietaryName": "Ethambutol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070810",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016320",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "ETHAMBUTOL HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70518-3070-2",
"PackageDescription": "100 POUCH in 1 BOX (70518-3070-2) / 1 TABLET in 1 POUCH (70518-3070-3) ",
"NDC11Code": "70518-3070-02",
"ProductNDC": "70518-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040159",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260720",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. C 24H 34O 4M.W. 386.53. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate."
},
{
"NDCCode": "71335-3070-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-3070-2) ",
"NDC11Code": "71335-3070-02",
"ProductNDC": "71335-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan And Hydrochlorothiazide",
"NonProprietaryName": "Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206083",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "320; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260206",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure < 140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure < 90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure < 130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure < 80 mmHg at Week 8. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).",
"Description": "Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide, and macrogol/peg 3350. Additionally the 80/12.5 mg, 160/25 mg and 320/25 mg strengths contain iron oxide red, FD&C blue #2 aluminum lake. The 160/12.5 mg and 320/12.5 mg strengths contain FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, FD&C blue #1 aluminum lake."
},
{
"NDCCode": "85512-3070-2",
"PackageDescription": "5 g in 1 BOTTLE (85512-3070-2) ",
"NDC11Code": "85512-3070-02",
"ProductNDC": "85512-3070",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Latanoprost",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "LATANOPROST",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-02-02",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-JAN-25"
},
{
"NDCCode": "0069-3070-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30) ",
"NDC11Code": "00069-3070-30",
"ProductNDC": "0069-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050784",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020524",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3070-75",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0069-3070-75) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00069-3070-75",
"ProductNDC": "0069-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050784",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020524",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "59762-0028-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (59762-0028-2) ",
"NDC11Code": "59762-0028-02",
"ProductNDC": "59762-0028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium And Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121101",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020607",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "50; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121101",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)].",
"Description": "Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium/misoprostol tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium/misoprostol 50) or 75 mg (diclofenac sodium/misoprostol 75) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium/misoprostol include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate."
},
{
"NDCCode": "59762-0030-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (59762-0030-2)",
"NDC11Code": "59762-0030-02",
"ProductNDC": "59762-0030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120803",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202468",
"LabelerName": "Greenstone LLC",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "59762-0035-2",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2) ",
"NDC11Code": "59762-0035-02",
"ProductNDC": "59762-0035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020895",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil citrate tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil citrate tablets, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil citrate tablets are formulated as white to off-white, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "59762-0036-2",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (59762-0036-2) ",
"NDC11Code": "59762-0036-02",
"ProductNDC": "59762-0036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020895",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil citrate tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil citrate tablets, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil citrate tablets are formulated as white to off-white, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin."
},
{
"NDCCode": "59762-0037-2",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59762-0037-2) ",
"NDC11Code": "59762-0037-02",
"ProductNDC": "59762-0037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160501",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020931",
"LabelerName": "Greenstone LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160501",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "59762-0038-2",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59762-0038-2) ",
"NDC11Code": "59762-0038-02",
"ProductNDC": "59762-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160501",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020931",
"LabelerName": "Greenstone LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160501",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "59762-0039-2",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59762-0039-2) ",
"NDC11Code": "59762-0039-02",
"ProductNDC": "59762-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160501",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020931",
"LabelerName": "Greenstone LLC",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160501",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "59762-0045-2",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (59762-0045-2)",
"NDC11Code": "59762-0045-02",
"ProductNDC": "59762-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120803",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202096",
"LabelerName": "Greenstone LLC",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
},
{
"NDCCode": "59762-0046-2",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE (59762-0046-2)",
"NDC11Code": "59762-0046-02",
"ProductNDC": "59762-0046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120803",
"EndMarketingDate": "20141031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202096",
"LabelerName": "Greenstone LLC",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-11-07"
},
{
"NDCCode": "59762-0047-2",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-2) ",
"NDC11Code": "59762-0047-02",
"ProductNDC": "59762-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate Extended Release",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160122",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021228",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160122",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].",
"Description": "Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone."
},
{
"NDCCode": "59762-0048-2",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-2) ",
"NDC11Code": "59762-0048-02",
"ProductNDC": "59762-0048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate Extended Release",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141230",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021228",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141230",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].",
"Description": "Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone."
},
{
"NDCCode": "59762-0055-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59762-0055-2) ",
"NDC11Code": "59762-0055-02",
"ProductNDC": "59762-0055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180819",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011839",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201102",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients. Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake."
},
{
"NDCCode": "59762-0056-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59762-0056-2) ",
"NDC11Code": "59762-0056-02",
"ProductNDC": "59762-0056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19590603",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011839",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200323",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients. Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake."
},
{
"NDCCode": "59762-0058-2",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59762-0058-2) ",
"NDC11Code": "59762-0058-02",
"ProductNDC": "59762-0058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Medroxyprogesterone Acetate",
"NonProprietaryName": "Medroxyprogesterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180820",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011839",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MEDROXYPROGESTERONE ACETATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200511",
"SamplePackage": "N",
"IndicationAndUsage": "Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.",
"Description": "Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients. Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake."
},
{
"NDCCode": "59762-0104-2",
"PackageDescription": "300 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-2) ",
"NDC11Code": "59762-0104-02",
"ProductNDC": "59762-0104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfasalazine",
"NonProprietaryName": "Sulfasalazine",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20050505",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA007073",
"LabelerName": "Greenstone LLC",
"SubstanceName": "SULFASALAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050505",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfasalazine delayed release tablets are indicated: 1 a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;, 2 b)for the prolongation of the remission period between acute attacks of ulcerative colitis;, 3 c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and, 4 d)in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.",
"Description": "Sulfasalazine delayed release tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration. Sulfasalazine delayed release tablets are film coated with cellulose acetate phthalate to retard disintegration of the tablet in the stomach and reduce potential irritation of the gastric mucosa. Therapeutic Classification: Anti-inflammatory agent and/or immunomodulatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. Molecular Formula: C18H14N4O5S. Inactive Ingredients: beeswax (white), carnauba wax, cellacefate, magnesium stearate, polyethylene glycol, povidone, propylene glycol, self-emulsifying glycerol monostearate, silica (colloidal anhydrous), starch (pregelatinized), talc."
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{
"NDCCode": "59762-0131-2",
"PackageDescription": "1 TUBE in 1 CARTON (59762-0131-2) / 25 g in 1 TUBE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silver Sulfadiazine",
"NonProprietaryName": "Silver Sulfadiazine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017381",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SILVER SULFADIAZINE",
"StrengthNumber": "10",
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"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
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"IndicationAndUsage": "Silver Sulfadiazine Cream 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.",
"Description": "Silver Sulfadiazine Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula. Each gram of silver sulfadiazine cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. Silver Sulfadiazine Cream 1% spreads easily and can be washed off readily with water."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"LabelerName": "Greenstone LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
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{
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"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (59762-0156-2) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Greenstone LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
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"PackageNdcExcludeFlag": "N",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
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"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020702",
"LabelerName": "Greenstone LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
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<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-09</LastUpdate>
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<PackageDescription>1 TUBE in 1 BLISTER PACK (10742-3070-1) / 4.2 g in 1 TUBE</PackageDescription>
<NDC11Code>10742-3070-01</NDC11Code>
<ProductNDC>10742-3070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mentholatum Natural Ice - Original, Spf 15</ProprietaryName>
<ProprietaryNameSuffix>Original</ProprietaryNameSuffix>
<NonProprietaryName>Dimethicone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Mentholatum Company</LabelerName>
<SubstanceName>OCTISALATE; DIMETHICONE; OCTINOXATE</SubstanceName>
<StrengthNumber>50; 10; 75</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather.</IndicationAndUsage>
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<NDC>
<NDCCode>36987-3070-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3070-2)</PackageDescription>
<NDC11Code>36987-3070-02</NDC11Code>
<ProductNDC>36987-3070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>California Black Walnut</ProprietaryName>
<NonProprietaryName>California Black Walnut</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS CALIFORNICA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3070-2</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-3070-2) </PackageDescription>
<NDC11Code>37662-3070-02</NDC11Code>
<ProductNDC>37662-3070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Strontium Metallicum</ProprietaryName>
<NonProprietaryName>Strontium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STRONTIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54569-3070-2</NDCCode>
<PackageDescription>98 TABLET, FILM COATED in 1 BOTTLE (54569-3070-2)</PackageDescription>
<NDC11Code>54569-3070-02</NDC11Code>
<ProductNDC>54569-3070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Myambutol</ProprietaryName>
<NonProprietaryName>Ethambutol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070810</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016320</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>ETHAMBUTOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-3070-2</NDCCode>
<PackageDescription>100 POUCH in 1 BOX (70518-3070-2) / 1 TABLET in 1 POUCH (70518-3070-3) </PackageDescription>
<NDC11Code>70518-3070-02</NDC11Code>
<ProductNDC>70518-3070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040159</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. C 24H 34O 4M.W. 386.53. Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>71335-3070-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71335-3070-2) </PackageDescription>
<NDC11Code>71335-3070-02</NDC11Code>
<ProductNDC>71335-3070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206083</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>320; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. Figure 1: Probability of Achieving Systolic Blood Pressure < 140 mmHg at Week 8. Figure 2: Probability of Achieving Diastolic Blood Pressure < 90 mmHg at Week 8. Figure 3: Probability of Achieving Systolic Blood Pressure < 130 mmHg at Week 8. Figure 4: Probability of Achieving Diastolic Blood Pressure < 80 mmHg at Week 8. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of < 140 mmHg (systolic) and 60% likelihood of achieving < 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
<Description>Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide, and macrogol/peg 3350. Additionally the 80/12.5 mg, 160/25 mg and 320/25 mg strengths contain iron oxide red, FD&C blue #2 aluminum lake. The 160/12.5 mg and 320/12.5 mg strengths contain FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, FD&C blue #1 aluminum lake.</Description>
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<PackageDescription>5 g in 1 BOTTLE (85512-3070-2) </PackageDescription>
<NDC11Code>85512-3070-02</NDC11Code>
<ProductNDC>85512-3070</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Latanoprost</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>LATANOPROST</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-02</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0069-3070-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30) </PackageDescription>
<NDC11Code>00069-3070-30</NDC11Code>
<ProductNDC>0069-3070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020524</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050784</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
<NDC>
<NDCCode>0069-3070-75</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0069-3070-75) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00069-3070-75</NDC11Code>
<ProductNDC>0069-3070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020524</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050784</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
<NDC>
<NDCCode>59762-0028-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (59762-0028-2) </PackageDescription>
<NDC11Code>59762-0028-02</NDC11Code>
<ProductNDC>59762-0028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121101</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020607</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium/misoprostol is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium/misoprostol tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium/misoprostol 50) or 75 mg (diclofenac sodium/misoprostol 75) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium/misoprostol include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>59762-0030-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (59762-0030-2)</PackageDescription>
<NDC11Code>59762-0030-02</NDC11Code>
<ProductNDC>59762-0030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202468</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59762-0035-2</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2) </PackageDescription>
<NDC11Code>59762-0035-02</NDC11Code>
<ProductNDC>59762-0035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020895</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil citrate tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil citrate tablets, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil citrate tablets are formulated as white to off-white, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>59762-0036-2</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (59762-0036-2) </PackageDescription>
<NDC11Code>59762-0036-02</NDC11Code>
<ProductNDC>59762-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020895</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil citrate tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil citrate tablets, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil citrate tablets are formulated as white to off-white, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>59762-0037-2</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59762-0037-2) </PackageDescription>
<NDC11Code>59762-0037-02</NDC11Code>
<ProductNDC>59762-0037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020931</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160501</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59762-0038-2</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59762-0038-2) </PackageDescription>
<NDC11Code>59762-0038-02</NDC11Code>
<ProductNDC>59762-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020931</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160501</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59762-0039-2</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59762-0039-2) </PackageDescription>
<NDC11Code>59762-0039-02</NDC11Code>
<ProductNDC>59762-0039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020931</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160501</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59762-0045-2</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (59762-0045-2)</PackageDescription>
<NDC11Code>59762-0045-02</NDC11Code>
<ProductNDC>59762-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202096</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59762-0046-2</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE (59762-0046-2)</PackageDescription>
<NDC11Code>59762-0046-02</NDC11Code>
<ProductNDC>59762-0046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<EndMarketingDate>20141031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202096</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-11-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>59762-0047-2</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0047-2) </PackageDescription>
<NDC11Code>59762-0047-02</NDC11Code>
<ProductNDC>59762-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate Extended Release</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160122</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021228</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160122</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>59762-0048-2</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-2) </PackageDescription>
<NDC11Code>59762-0048-02</NDC11Code>
<ProductNDC>59762-0048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate Extended Release</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141230</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021228</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141230</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Tolterodine tartrate extended-release capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of tolterodine tartrate is C26H37NO7. Its structure is. Tolterodine tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Tolterodine tartrate extended-release capsules 4 mg capsule for oral administration contains 4 mg of tolterodine tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. Tolterodine tartrate extended-release capsules 2 mg capsule for oral administration contains 2 mg of tolterodine tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2. Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>59762-0055-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59762-0055-2) </PackageDescription>
<NDC11Code>59762-0055-02</NDC11Code>
<ProductNDC>59762-0055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180819</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA011839</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients. Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59762-0056-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59762-0056-2) </PackageDescription>
<NDC11Code>59762-0056-02</NDC11Code>
<ProductNDC>59762-0056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19590603</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA011839</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients. Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59762-0058-2</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59762-0058-2) </PackageDescription>
<NDC11Code>59762-0058-02</NDC11Code>
<ProductNDC>59762-0058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
<NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180820</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA011839</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.</IndicationAndUsage>
<Description>Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is. Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients. Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59762-0104-2</NDCCode>
<PackageDescription>300 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-2) </PackageDescription>
<NDC11Code>59762-0104-02</NDC11Code>
<ProductNDC>59762-0104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfasalazine</ProprietaryName>
<NonProprietaryName>Sulfasalazine</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050505</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA007073</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>SULFASALAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050505</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfasalazine delayed release tablets are indicated: 1 a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;, 2 b)for the prolongation of the remission period between acute attacks of ulcerative colitis;, 3 c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and, 4 d)in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.</IndicationAndUsage>
<Description>Sulfasalazine delayed release tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration. Sulfasalazine delayed release tablets are film coated with cellulose acetate phthalate to retard disintegration of the tablet in the stomach and reduce potential irritation of the gastric mucosa. Therapeutic Classification: Anti-inflammatory agent and/or immunomodulatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure. Molecular Formula: C18H14N4O5S. Inactive Ingredients: beeswax (white), carnauba wax, cellacefate, magnesium stearate, polyethylene glycol, povidone, propylene glycol, self-emulsifying glycerol monostearate, silica (colloidal anhydrous), starch (pregelatinized), talc.</Description>
</NDC>
<NDC>
<NDCCode>59762-0131-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59762-0131-2) / 25 g in 1 TUBE</PackageDescription>
<NDC11Code>59762-0131-02</NDC11Code>
<ProductNDC>59762-0131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silver Sulfadiazine</ProprietaryName>
<NonProprietaryName>Silver Sulfadiazine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017381</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SILVER SULFADIAZINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silver Sulfadiazine Cream 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.</IndicationAndUsage>
<Description>Silver Sulfadiazine Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula. Each gram of silver sulfadiazine cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. Silver Sulfadiazine Cream 1% spreads easily and can be washed off readily with water.</Description>
</NDC>
<NDC>
<NDCCode>59762-0155-2</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (59762-0155-2) </PackageDescription>
<NDC11Code>59762-0155-02</NDC11Code>
<ProductNDC>59762-0155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130128</StartMarketingDate>
<EndMarketingDate>20230630</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130128</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59762-0156-2</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (59762-0156-2) </PackageDescription>
<NDC11Code>59762-0156-02</NDC11Code>
<ProductNDC>59762-0156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130128</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130128</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59762-0157-2</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59762-0157-2) </PackageDescription>
<NDC11Code>59762-0157-02</NDC11Code>
<ProductNDC>59762-0157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130128</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Greenstone 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>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130128</StartMarketingDatePackage>
<EndMarketingDatePackage>20230831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>