RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "83163-386-00",
      "PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (83163-386-00)  / 59.14 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "83163-0386-00",
      "ProductNDC": "83163-386",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Waxup Numbing",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20221223",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M015",
      "LabelerName": "CONSTRUSOLUTION, LLC",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2023-11-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221223",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps relieve the local itching and discomfort in the perianal area. For the temporary relief of pain, irritation or burning."
    },
    {
      "NDCCode": "55150-386-00",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (55150-386-00)  / 60 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "55150-0386-00",
      "ProductNDC": "55150-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carboplatin",
      "NonProprietaryName": "Carboplatin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200803",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205487",
      "LabelerName": "Eugia US LLC",
      "SubstanceName": "CARBOPLATIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/60mL",
      "Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200803",
      "SamplePackage": "N",
      "IndicationAndUsage": "Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.",
      "Description": "Carboplatin injection, USP is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. Each mL contains 10 mg carboplatin, USP, 10 mg mannitol and water for injection, USP.  Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1,1-cyclobutanedicarboxylato (2-)-O,O']-, (SP-4-2), and carboplatin, USP has the following structural formula:.  Carboplatin, USP is a white to off white crystalline solid. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
    },
    {
      "NDCCode": "67457-386-81",
      "PackageDescription": "4 VIAL in 1 CARTON (67457-386-81)  / 20 mL in 1 VIAL (67457-386-00) ",
      "NDC11Code": "67457-0386-81",
      "ProductNDC": "67457-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mycophenolate Mofetil",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203859",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white or almost white, crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.7 to 4.1. Mycophenolate mofetil for injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate mofetil for injection, USP is available as a sterile white to off-white lyophilized powder, plug or cake in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil, USP equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of mycophenolate mofetil for injection to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "68001-386-00",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-386-00) ",
      "NDC11Code": "68001-0386-00",
      "ProductNDC": "68001-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrofurantion",
      "NonProprietaryName": "Nitrofurantion",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201722",
      "LabelerName": "BluePoint Labortories",
      "SubstanceName": "NITROFURANTOIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
      "Status": "Active",
      "LastUpdate": "2019-05-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190514",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nitrofurantoin Capsules, USP (macrocrystals) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci. Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules, USP (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules, USP (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
      "Description": "Nitrofurantoin macrocrystals, USP is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin macrocrystals, USP is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. It is chemically designated as 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione and has the following structural formula. Each Nitrofurantoin Capsules, USP (macrocrystals) contains nitrofurantoin (macrocrystals) USP equivalent to 25 mg, 50 mg or 100 mg and the following inactive ingredients: lactose monohydrate, corn starch, talc, titanium dioxide, gelatin, sodium lauryl sulfate, shellac, propylene glycol, potassium hydroxide and black iron oxide. In addition 50 mg capsules contain FD&C Blue #1, red iron oxide and yellow iron oxide."
    },
    {
      "NDCCode": "76420-386-00",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (76420-386-00) ",
      "NDC11Code": "76420-0386-00",
      "ProductNDC": "76420-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070322",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.",
      "Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. C ​16​H ​21​NO ​2​HCl M.W. 295.80. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (40 mg and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg)."
    },
    {
      "NDCCode": "50090-0166-0",
      "PackageDescription": "10 TABLET in 1 BOTTLE (50090-0166-0) ",
      "NDC11Code": "50090-0166-00",
      "ProductNDC": "50090-0166",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160621",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "50090-0573-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (50090-0573-0)  > 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "50090-0573-00",
      "ProductNDC": "50090-0573",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".625; 2.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170101",
      "SamplePackage": "N",
      "IndicationAndUsage": "PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2), 3 Prevention of Postmenopausal Osteoporosis (1.3).",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "54868-3799-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-3799-0)  > 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "54868-3799-00",
      "ProductNDC": "54868-3799",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960620",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".625; 2.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "PREMPRO/PREMPHASE is an estrogen/progestin indicated in women with intact uteri for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2), 3 Prevention of Postmenopausal Osteoporosis (1.3).",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α‑estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is."
    },
    {
      "NDCCode": "54868-3800-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-3800-0)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "54868-3800-00",
      "ProductNDC": "54868-3800",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Premphase",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20050708",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075796",
      "LabelerName": "Physicians Total Care, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "PREMPRO/PREMPHASE is an estrogen/progestin indicated in women with intact uteri for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2), 3 Prevention of Postmenopausal Osteoporosis (1.3).",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α‑estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is."
    },
    {
      "NDCCode": "54868-4866-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-4866-0)  > 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "54868-4866-00",
      "ProductNDC": "54868-4866",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030725",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".45; 1.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "PREMPRO/PREMPHASE is an estrogen/progestin indicated in women with intact uteri for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2), 3 Prevention of Postmenopausal Osteoporosis (1.3).",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α‑estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is."
    },
    {
      "NDCCode": "54868-5047-0",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-5047-0)  > 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "54868-5047-00",
      "ProductNDC": "54868-5047",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040408",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".3; 1.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "PREMPRO/PREMPHASE is an estrogen/progestin indicated in women with intact uteri for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2), 3 Prevention of Postmenopausal Osteoporosis (1.3).",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α‑estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is."
    },
    {
      "NDCCode": "70518-4666-0",
      "PackageDescription": "50 POUCH in 1 BOX (70518-4666-0)  / 1 TABLET in 1 POUCH (70518-4666-1) ",
      "NDC11Code": "70518-4666-00",
      "ProductNDC": "70518-4666",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260527",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260527",
      "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 4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0046-1105-11",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1105-11)  / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "00046-1105-11",
      "ProductNDC": "0046-1105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".3; 1.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090921",
      "SamplePackage": "N",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "0046-1106-11",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1106-11)  / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "00046-1106-11",
      "ProductNDC": "0046-1106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".45; 1.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090921",
      "SamplePackage": "N",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "0046-1107-11",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1107-11)  / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "00046-1107-11",
      "ProductNDC": "0046-1107",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".625; 2.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20090921",
      "SamplePackage": "N",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "0046-1108-11",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-1108-11)  / 28 TABLET, SUGAR COATED in 1 BLISTER PACK",
      "NDC11Code": "00046-1108-11",
      "ProductNDC": "0046-1108",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prempro",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET, SUGAR COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121203",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "SubstanceName": "ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": ".625; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20121203",
      "SamplePackage": "N",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "0046-2575-12",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0046-2575-12)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00046-2575-12",
      "ProductNDC": "0046-2575",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Premphase",
      "NonProprietaryName": "Conjugated Estrogens And Medroxyprogesterone Acetate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020527",
      "LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
      "Status": "Active",
      "LastUpdate": "2026-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120301",
      "SamplePackage": "N",
      "Description": "Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone. It is a white to off-white, odorless, crystalline powder, stable in air, melting between 200°C 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 MPA is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. Its molecular formula is C24H34O4, with a molecular weight of 386.53. Its structural formula is. PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide, yellow iron oxide, propylene glycol and black iron oxide. PREMPRO 0.625 mg/2.5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, microcrystalline cellulose, carnauba wax, hypromellose, hydroxypropyl cellulose, sucrose, Eudragit NE 30D, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, titanium dioxide, red iron oxide, yellow iron oxide, and black iron oxide. PREMPRO 0.625 mg/5 mg tablets contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, Eudragit NE 30D, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, titanium dioxide, triethyl citrate, FD&C Blue No. 2, black iron oxide, and propylene glycol."
    },
    {
      "NDCCode": "0069-0145-01",
      "PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01) ",
      "NDC11Code": "00069-0145-01",
      "ProductNDC": "0069-0145",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Inlyta",
      "NonProprietaryName": "Axitinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120127",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202324",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "AXITINIB",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120127",
      "SamplePackage": "N",
      "IndicationAndUsage": "INLYTA is a kinase inhibitor indicated: 1 in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (1.1), 2 in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (1.1), 3 as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. (1.2).",
      "Description": "INLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structure is. Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 µg/mL. The partition coefficient (n-octanol/water) is 3.5. INLYTA is supplied as red, film-coated tablets containing either 1 mg or 5 mg of axitinib together with microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose monohydrate, HPMC 2910/Hypromellose 15cP, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide."
    },
    {
      "NDCCode": "0069-0151-11",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11) ",
      "NDC11Code": "00069-0151-11",
      "ProductNDC": "0069-0151",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Inlyta",
      "NonProprietaryName": "Axitinib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120127",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA202324",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "AXITINIB",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20120127",
      "SamplePackage": "N",
      "IndicationAndUsage": "INLYTA is a kinase inhibitor indicated: 1 in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). (1.1), 2 in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (1.1), 3 as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. (1.2).",
      "Description": "INLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structure is. Axitinib is a white to light-yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 µg/mL. The partition coefficient (n-octanol/water) is 3.5. INLYTA is supplied as red, film-coated tablets containing either 1 mg or 5 mg of axitinib together with microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry® II red 32K15441 as inactive ingredients. The Opadry II red 32K15441 film coating contains lactose monohydrate, HPMC 2910/Hypromellose 15cP, titanium dioxide, triacetin (glycerol triacetate), and red iron oxide."
    },
    {
      "NDCCode": "0069-0305-01",
      "PackageDescription": "1 KIT in 1 KIT (0069-0305-01)  *  20 mL in 1 VIAL, MULTI-DOSE (0069-0306-01)  *  20 mL in 1 VIAL (0069-0307-01) ",
      "NDC11Code": "00069-0305-01",
      "ProductNDC": "0069-0305",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trazimera",
      "NonProprietaryName": "Trastuzumab-qyyp",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20200224",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761081",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200224",
      "SamplePackage": "N",
      "IndicationAndUsage": "TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
      "Description": "Trastuzumab-qyyp is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-qyyp is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. TRAZIMERA (trastuzumab-qyyp) for injection is a sterile, white, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of TRAZIMERA delivers 420 mg trastuzumab-qyyp, 7.9 mg L-histidine, 9.5 mg L-histidine HCl monohydrate, 1.7 mg polysorbate 20, and 386 mg sucrose. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-qyyp that delivers 20 mL (420 mg trastuzumab-qyyp), at a pH of approximately 6. If TRAZIMERA is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of TRAZIMERA delivers 150 mg trastuzumab-qyyp, 2.8 mg L-histidine, 3.4 mg L-histidine HCl monohydrate, 0.6 mg polysorbate 20, and 138 mg sucrose. Reconstitution with 7.4 mL of SWFI yields a solution containing 21 mg/mL trastuzumab-qyyp that delivers 7.15 mL (150 mg trastuzumab-qyyp), at a pH of approximately 6."
    },
    {
      "NDCCode": "0069-0308-01",
      "PackageDescription": "1 VIAL in 1 CARTON (0069-0308-01)  / 7.15 mL in 1 VIAL",
      "NDC11Code": "00069-0308-01",
      "ProductNDC": "0069-0308",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trazimera",
      "NonProprietaryName": "Trastuzumab-qyyp",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210310",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761081",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "TRASTUZUMAB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/7.15mL",
      "Pharm_Classes": "HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210310",
      "SamplePackage": "N",
      "IndicationAndUsage": "TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
      "Description": "Trastuzumab-qyyp is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-qyyp is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. TRAZIMERA (trastuzumab-qyyp) for injection is a sterile, white, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of TRAZIMERA delivers 420 mg trastuzumab-qyyp, 7.9 mg L-histidine, 9.5 mg L-histidine HCl monohydrate, 1.7 mg polysorbate 20, and 386 mg sucrose. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-qyyp that delivers 20 mL (420 mg trastuzumab-qyyp), at a pH of approximately 6. If TRAZIMERA is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of TRAZIMERA delivers 150 mg trastuzumab-qyyp, 2.8 mg L-histidine, 3.4 mg L-histidine HCl monohydrate, 0.6 mg polysorbate 20, and 138 mg sucrose. Reconstitution with 7.4 mL of SWFI yields a solution containing 21 mg/mL trastuzumab-qyyp that delivers 7.15 mL (150 mg trastuzumab-qyyp), at a pH of approximately 6."
    },
    {
      "NDCCode": "0555-0779-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0555-0779-02) ",
      "NDC11Code": "00555-0779-02",
      "ProductNDC": "0555-0779",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0555-0779-04",
      "PackageDescription": "500 TABLET in 1 BOTTLE (0555-0779-04) ",
      "NDC11Code": "00555-0779-04",
      "ProductNDC": "0555-0779",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0555-0872-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0555-0872-02) ",
      "NDC11Code": "00555-0872-02",
      "ProductNDC": "0555-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0555-0872-04",
      "PackageDescription": "500 TABLET in 1 BOTTLE (0555-0872-04) ",
      "NDC11Code": "00555-0872-04",
      "ProductNDC": "0555-0872",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0555-0873-02",
      "PackageDescription": "100 TABLET in 1 BOTTLE (0555-0873-02) ",
      "NDC11Code": "00555-0873-02",
      "ProductNDC": "0555-0873",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0555-0873-04",
      "PackageDescription": "500 TABLET in 1 BOTTLE (0555-0873-04) ",
      "NDC11Code": "00555-0873-04",
      "ProductNDC": "0555-0873",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Medroxyprogesterone Acetate",
      "NonProprietaryName": "Medroxyprogesterone Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040159",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "SubstanceName": "MEDROXYPROGESTERONE ACETATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-06-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19961204",
      "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.                                      C24H34O4        M.W. 386.53. Each medroxyprogesterone acetate 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": "0597-0035-10",
      "PackageDescription": "2 VIAL, GLASS in 1 CARTON (0597-0035-10)  / 7.5 mL in 1 VIAL, GLASS",
      "NDC11Code": "00597-0035-10",
      "ProductNDC": "0597-0035",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spevigo",
      "NonProprietaryName": "Spesolimab-sbzo",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20220901",
      "EndMarketingDate": "20271130",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761244",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "SPESOLIMAB",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-36 Receptor Antagonist [EPC], Interleukin-36 Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20220901",
      "EndMarketingDatePackage": "20271130",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.",
      "Description": "Spesolimab-sbzo, an interleukin-36 receptor antagonist, is a humanized monoclonal IgG1 antibody (mAb) against human IL-36R produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Spesolimab-sbzo has a molecular weight of approximately 146 kDa. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 2 mL prefilled syringe contains 300 mg spesolimab-sbzo, arginine hydrochloride (10.6 mg), glacial acetic acid (0.64 mg), polysorbate 20 (0.80 mg), sodium acetate (6.50 mg), sucrose (102.8 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. Each 1 mL prefilled syringe contains 150 mg spesolimab-sbzo, arginine hydrochloride (5.3 mg), glacial acetic acid (0.32 mg), polysorbate 20 (0.40 mg), sodium acetate (3.25 mg), sucrose (51.4 mg), and Water for Injection, USP with a pH of 5.2 to 5.8. SPEVIGO (spesolimab-sbzo) injection is a sterile, preservative-free, colorless to slightly brownish-yellow, clear to slightly opalescent solution supplied in a single-dose vial for intravenous use. Each 7.5 mL vial contains 450 mg spesolimab-sbzo, arginine hydrochloride (39.5 mg), glacial acetic acid (2.4 mg), polysorbate 20 (3.0 mg), sodium acetate (24.5 mg), sucrose (386 mg), and Water for Injection, USP with a pH of 5.2 to 5.8."
    },
    {
      "NDCCode": "0597-0155-28",
      "PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0155-28)  / 28 SPRAY, METERED in 1 CARTRIDGE",
      "NDC11Code": "00597-0155-28",
      "ProductNDC": "0597-0155",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stiolto Respimat",
      "NonProprietaryName": "Tiotropium Bromide And Olodaterol",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150521",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206756",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE",
      "StrengthNumber": "3.124; 2.736",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150521",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1). Important limitations: 1 STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.1), 2 STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1).",
      "Description": "STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). The drug substance tiotropium bromide monohydrate is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug substance olodaterol hydrochloride is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094. The structural formula is. The drug product, STIOLTO RESPIMAT, is composed of a sterile aqueous solution of tiotropium bromide and olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STIOLTO RESPIMAT cartridge) for use with the STIOLTO RESPIMAT inhaler. Excipients include, benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STIOLTO RESPIMAT inhaler has a light green-colored cap. When used with the STIOLTO RESPIMAT inhaler each cartridge, containing 4 grams of sterile aqueous solution, delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) and 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds)."
    },
    {
      "NDCCode": "0597-0155-61",
      "PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0155-61)  / 60 SPRAY, METERED in 1 CARTRIDGE",
      "NDC11Code": "00597-0155-61",
      "ProductNDC": "0597-0155",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Stiolto Respimat",
      "NonProprietaryName": "Tiotropium Bromide And Olodaterol",
      "DosageFormName": "SPRAY, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20150521",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA206756",
      "LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "SubstanceName": "TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE",
      "StrengthNumber": "3.124; 2.736",
      "StrengthUnit": "ug/1; ug/1",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150521",
      "SamplePackage": "N",
      "IndicationAndUsage": "STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1). Important limitations: 1 STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. (1.1), 2 STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1).",
      "Description": "STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). The drug substance tiotropium bromide monohydrate is chemically described as (1α, 2ß, 4ß, 5α, 7ß)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug substance olodaterol hydrochloride is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094. The structural formula is. The drug product, STIOLTO RESPIMAT, is composed of a sterile aqueous solution of tiotropium bromide and olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STIOLTO RESPIMAT cartridge) for use with the STIOLTO RESPIMAT inhaler. Excipients include, benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The STIOLTO RESPIMAT cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. The STIOLTO RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STIOLTO RESPIMAT inhaler has a light green-colored cap. When used with the STIOLTO RESPIMAT inhaler each cartridge, containing 4 grams of sterile aqueous solution, delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the STIOLTO RESPIMAT inhaler delivers 5 mcg tiotropium (equivalent to 6.247 mcg tiotropium bromide monohydrate) and 5 mcg olodaterol (equivalent to 5.473 mcg olodaterol hydrochloride) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds)."
    }
  ]
}
                    

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