{
"NDC": [
{
"NDCCode": "50090-0823-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-0823-0)",
"NDC11Code": "50090-0823-00",
"ProductNDC": "50090-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075743",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "50090-0823-2",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-0823-2)",
"NDC11Code": "50090-0823-02",
"ProductNDC": "50090-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075743",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "54868-0823-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-0823-0)",
"NDC11Code": "54868-0823-00",
"ProductNDC": "54868-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felodipine",
"NonProprietaryName": "Felodipine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075896",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "FELODIPINE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Felodipine is indicated for the treatment of hypertension. Felodipine may be used alone or concomitantly with other antihypertensive agents.",
"Description": "Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture. Felodipine tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: felodipine tablets 2.5 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 5 mg — carnauba wax, D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 10 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. The USP drug release test # is pending."
},
{
"NDCCode": "60505-0823-0",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (60505-0823-0) / 14 SPRAY, METERED in 1 BOTTLE, GLASS",
"NDC11Code": "60505-0823-00",
"ProductNDC": "60505-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitonin Salmon",
"NonProprietaryName": "Calcitonin Salmon",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20081209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076396",
"LabelerName": "Apotex Corp.",
"SubstanceName": "CALCITONIN SALMON",
"StrengthNumber": "200",
"StrengthUnit": "[iU]/1",
"Pharm_Classes": "Calcitonin [CS], Calcitonin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081209",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitonin Salmon (synthetic origin) Nasal Spray is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated (1.1). Limitations of Use: 1 Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis (1.2, 5.4), 2 Calcitonin salmon nasal spray has not been shown to increase bone mineral density in early postmenopausal women (1.2).",
"Description": "Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin Salmon (synthetic origin) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in a 2 mL or 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 14 doses (2 mL fill) or 30 doses (3.7 mL fill). Active Ingredient: calcitonin salmon 2200 USP Calcitonin Salmon Units per mL (corresponding to 200 USP Calcitonin Salmon Units per 0.09 mL actuation). Inactive Ingredients: benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH), purified water and sodium chloride. The activity of calcitonin salmon nasal spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute of Biological Standards and Control, Holly Hill, London."
},
{
"NDCCode": "60905-0823-0",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (60905-0823-0) ",
"NDC11Code": "60905-0823-00",
"ProductNDC": "60905-0823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 P340",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "LVMH FRAGRANCE BRANDS",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions."
},
{
"NDCCode": "71335-0823-0",
"PackageDescription": "2 CAPSULE in 1 BOTTLE (71335-0823-0) ",
"NDC11Code": "71335-0823-00",
"ProductNDC": "71335-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150528",
"EndMarketingDate": "20221031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204446",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211227",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N"
},
{
"NDCCode": "0245-0823-04",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) ",
"NDC11Code": "00245-0823-04",
"ProductNDC": "0245-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0823-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0245-0823-30) ",
"NDC11Code": "00245-0823-30",
"ProductNDC": "0245-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240624",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "17856-0823-1",
"PackageDescription": "10 mL in 1 CUP (17856-0823-1) ",
"NDC11Code": "17856-0823-01",
"ProductNDC": "17856-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19971229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074650",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190920",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is -(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C H N O S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is: N1101133. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C H N O . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is: 141843. alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor. Inactive ingredients."
},
{
"NDCCode": "17856-0823-5",
"PackageDescription": "5 mL in 1 CUP (17856-0823-5) ",
"NDC11Code": "17856-0823-05",
"ProductNDC": "17856-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19971229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074650",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160504",
"EndMarketingDatePackage": "20190927",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is -(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C H N O S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is: N1101133. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C H N O . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is: 141843. alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor. Inactive ingredients."
},
{
"NDCCode": "21695-823-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-823-30)",
"NDC11Code": "21695-0823-30",
"ProductNDC": "21695-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076549",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ramipril capsules are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).",
"Description": "Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Ramipril is supplied as hard shell capsules for oral administration containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10, D&C red #28, FD&C red #40 and yellow iron oxide, the 5 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains D&C red #28, FD&C blue #1, FD&C red #40 and black iron oxide."
},
{
"NDCCode": "23155-823-73",
"PackageDescription": "8 TABLET in 1 BOTTLE (23155-823-73) ",
"NDC11Code": "23155-0823-73",
"ProductNDC": "23155-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabergoline",
"NonProprietaryName": "Cabergoline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076310",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "CABERGOLINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.",
"Description": "Cabergoline Tablets, USP contain Cabergoline USP, a dopamine receptor agonist. The chemical name for Cabergoline USP is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(di- methylamino)propyl]-3-ethylurea. Its molecular formula is C26H37N5O2, and its molecular weight is 451.62. The structural formula is as follows. Cabergoline USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water. Each tablet, for oral administration, contains 0.5 mg of Cabergoline USP. Inactive ingredients consist of citric acid, croscarmellose sodium, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "43063-823-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20) ",
"NDC11Code": "43063-0823-20",
"ProductNDC": "43063-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065489",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180108",
"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) , 2 Acute Maxillary Sinusitis ( 1.2) , 3 Community-Acquired Pneumonia ( 1.3) , 4 Pharyngitis/Tonsillitis ( 1.4) , 5 Uncomplicated Skin and Skin Structure Infections ( 1.5) , 6 Acute Otitis Media in Pediatric Patients ( 1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) , 8 Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults ( 1.8) .",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid."
},
{
"NDCCode": "43063-823-28",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28) ",
"NDC11Code": "43063-0823-28",
"ProductNDC": "43063-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065489",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180222",
"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) , 2 Acute Maxillary Sinusitis ( 1.2) , 3 Community-Acquired Pneumonia ( 1.3) , 4 Pharyngitis/Tonsillitis ( 1.4) , 5 Uncomplicated Skin and Skin Structure Infections ( 1.5) , 6 Acute Otitis Media in Pediatric Patients ( 1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) , 8 Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults ( 1.8) .",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid."
},
{
"NDCCode": "50268-823-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-823-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-823-11) ",
"NDC11Code": "50268-0823-15",
"ProductNDC": "50268-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077670",
"LabelerName": "AvPAK",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251009",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 112.0 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Ascorbic acid (in 25 mg, 50 mg and 100 mg tablets), D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance."
},
{
"NDCCode": "50383-823-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-823-16) ",
"NDC11Code": "50383-0823-16",
"ProductNDC": "50383-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19971229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074650",
"LabelerName": "Akorn Operating Company LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19971229",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis jiroveci pneumonia. Traveler’s Diarrhea In Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension is a synthetic antibacterial combination product available for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor."
},
{
"NDCCode": "58160-823-11",
"PackageDescription": "1 KIT in 1 CARTON (58160-823-11) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) ",
"NDC11Code": "58160-0823-11",
"ProductNDC": "58160-823",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Shingrix",
"NonProprietaryName": "Zoster Vaccine Recombinant, Adjuvanted",
"DosageFormName": "KIT",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125614",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): 1 in adults aged 50 years and older., 2 in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.",
"Description": "SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile injectable suspension for intramuscular use that contains recombinant varicella zoster virus gE antigen adjuvanted with AS01B. The vial and vial presentation is supplied as a vial of lyophilized recombinant varicella zoster virus surface gE antigen component (Lyophilized gE Antigen Component), which must be reconstituted at the time of use with the accompanying vial of AS01B (Adjuvant Suspension Component) to form SHINGRIX. The SHINGRIX prefilled syringe presentation does not require reconstitution. SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal‑derived proteins. The gE protein is purified by several chromatographic steps and formulated with excipients. The AS01B adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) derived from Salmonella minnesota and QS‑21, a saponin purified from Quillaja saponaria Molina plant extract, and is combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. Each 0.5‑mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS‑21. Each dose also contains 20 mg of sucrose, 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate (applicable to prefilled syringe presentation only), 0.160 mg of sodium dihydrogen phosphate anhydrous (applicable to vial and vial presentation only), 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. SHINGRIX does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process. In the vial and vial presentation, the vial stoppers are not made with natural rubber latex. In the prefilled syringe presentation, the tip cap and rubber plunger stopper are not made with natural rubber latex."
},
{
"NDCCode": "60505-0823-6",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (60505-0823-6) / 30 SPRAY, METERED in 1 BOTTLE, GLASS",
"NDC11Code": "60505-0823-06",
"ProductNDC": "60505-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitonin Salmon",
"NonProprietaryName": "Calcitonin Salmon",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20081209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076396",
"LabelerName": "Apotex Corp.",
"SubstanceName": "CALCITONIN SALMON",
"StrengthNumber": "200",
"StrengthUnit": "[iU]/1",
"Pharm_Classes": "Calcitonin [CS], Calcitonin [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081209",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitonin Salmon (synthetic origin) Nasal Spray is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated (1.1). Limitations of Use: 1 Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis (1.2, 5.4), 2 Calcitonin salmon nasal spray has not been shown to increase bone mineral density in early postmenopausal women (1.2).",
"Description": "Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin Salmon (synthetic origin) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in a 2 mL or 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 14 doses (2 mL fill) or 30 doses (3.7 mL fill). Active Ingredient: calcitonin salmon 2200 USP Calcitonin Salmon Units per mL (corresponding to 200 USP Calcitonin Salmon Units per 0.09 mL actuation). Inactive Ingredients: benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH), purified water and sodium chloride. The activity of calcitonin salmon nasal spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute of Biological Standards and Control, Holly Hill, London."
},
{
"NDCCode": "62135-823-84",
"PackageDescription": "6 POUCH in 1 CARTON (62135-823-84) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE",
"NDC11Code": "62135-0823-84",
"ProductNDC": "62135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Budesonide",
"NonProprietaryName": "Budesonide",
"DosageFormName": "SUSPENSION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078202",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240130",
"SamplePackage": "N",
"Description": "Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25H 34O 6and its molecular weight is 430.5. Its structural formula is:. Budesonide is a white or almost white, crystalline powder that is practically insoluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients citric acid, edetate disodium dihydrate, polysorbate 80, sodium chloride, sodium citrate, and water for injection. Two dose strengths are available in single-dose ampules: 0.25 mg and 0.5 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitroconditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration(2)]."
},
{
"NDCCode": "63323-823-20",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01) ",
"NDC11Code": "63323-0823-20",
"ProductNDC": "63323-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ertapenem",
"NonProprietaryName": "Ertapenem Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20191010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208790",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ERTAPENEM SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191010",
"SamplePackage": "N",
"IndicationAndUsage": "Ertapenem for Injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: : 1 Complicated intra-abdominal infections. ( 1.1) , 2 Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2) , 3 Community-acquired pneumonia. ( 1.3) , 4 Complicated urinary tract infections including pyelonephritis. ( 1.4) , 5 Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections. ( 1.5) .",
"Description": "Ertapenem for Injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for Injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo [3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.5. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for Injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration ( 2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6 mEq). Each vial of Ertapenem for Injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5."
},
{
"NDCCode": "67296-0823-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (67296-0823-1) ",
"NDC11Code": "67296-0823-01",
"ProductNDC": "67296-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20070307",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Osteoarthritis (OA). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. [Chemical Structure]. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "67296-0823-5",
"PackageDescription": "5 TABLET in 1 BOTTLE (67296-0823-5) ",
"NDC11Code": "67296-0823-05",
"ProductNDC": "67296-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20070307",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Osteoarthritis (OA). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. [Chemical Structure]. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "67296-0823-7",
"PackageDescription": "7 TABLET in 1 BOTTLE (67296-0823-7) ",
"NDC11Code": "67296-0823-07",
"ProductNDC": "67296-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20070307",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Osteoarthritis (OA). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. [Chemical Structure]. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "71610-823-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71610-823-30) ",
"NDC11Code": "71610-0823-30",
"ProductNDC": "71610-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211685",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240422",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "71610-823-46",
"PackageDescription": "56 CAPSULE in 1 BOTTLE (71610-823-46) ",
"NDC11Code": "71610-0823-46",
"ProductNDC": "71610-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211685",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240422",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "71610-823-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71610-823-53) ",
"NDC11Code": "71610-0823-53",
"ProductNDC": "71610-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211685",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240422",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "71610-823-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71610-823-60) ",
"NDC11Code": "71610-0823-60",
"ProductNDC": "71610-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211685",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240422",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "71610-823-80",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (71610-823-80) ",
"NDC11Code": "71610-0823-80",
"ProductNDC": "71610-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211685",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240422",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "50090-0001-0",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (50090-0001-0) / 1 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "50090-0001-00",
"ProductNDC": "50090-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"ProprietaryNameSuffix": "For Children",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20101214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070607",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily : 1 reduces fever , 2 relieves minor aches, pains, and headache."
},
{
"NDCCode": "50090-0002-0",
"PackageDescription": "1000 TABLET in 1 BOTTLE (50090-0002-0) ",
"NDC11Code": "50090-0002-00",
"ProductNDC": "50090-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pharbest Regular Strength Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50090-0823-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-0823-0)</PackageDescription>
<NDC11Code>50090-0823-00</NDC11Code>
<ProductNDC>50090-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075743</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>50090-0823-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-0823-2)</PackageDescription>
<NDC11Code>50090-0823-02</NDC11Code>
<ProductNDC>50090-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075743</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>54868-0823-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54868-0823-0)</PackageDescription>
<NDC11Code>54868-0823-00</NDC11Code>
<ProductNDC>54868-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felodipine</ProprietaryName>
<NonProprietaryName>Felodipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075896</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>FELODIPINE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Felodipine is indicated for the treatment of hypertension. Felodipine may be used alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C18H19Cl2NO4 and its structural formula is. Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture. Felodipine tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: felodipine tablets 2.5 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 5 mg — carnauba wax, D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 10 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. The USP drug release test # is pending.</Description>
</NDC>
<NDC>
<NDCCode>60505-0823-0</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (60505-0823-0) / 14 SPRAY, METERED in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>60505-0823-00</NDC11Code>
<ProductNDC>60505-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitonin Salmon</ProprietaryName>
<NonProprietaryName>Calcitonin Salmon</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20081209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076396</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>CALCITONIN SALMON</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[iU]/1</StrengthUnit>
<Pharm_Classes>Calcitonin [CS], Calcitonin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitonin Salmon (synthetic origin) Nasal Spray is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated (1.1). Limitations of Use: 1 Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis (1.2, 5.4), 2 Calcitonin salmon nasal spray has not been shown to increase bone mineral density in early postmenopausal women (1.2).</IndicationAndUsage>
<Description>Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin Salmon (synthetic origin) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in a 2 mL or 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 14 doses (2 mL fill) or 30 doses (3.7 mL fill). Active Ingredient: calcitonin salmon 2200 USP Calcitonin Salmon Units per mL (corresponding to 200 USP Calcitonin Salmon Units per 0.09 mL actuation). Inactive Ingredients: benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH), purified water and sodium chloride. The activity of calcitonin salmon nasal spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute of Biological Standards and Control, Holly Hill, London.</Description>
</NDC>
<NDC>
<NDCCode>60905-0823-0</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (60905-0823-0) </PackageDescription>
<NDC11Code>60905-0823-00</NDC11Code>
<ProductNDC>60905-0823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 P340</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LVMH FRAGRANCE BRANDS</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-0823-0</NDCCode>
<PackageDescription>2 CAPSULE in 1 BOTTLE (71335-0823-0) </PackageDescription>
<NDC11Code>71335-0823-00</NDC11Code>
<ProductNDC>71335-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150528</StartMarketingDate>
<EndMarketingDate>20221031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204446</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0245-0823-04</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) </PackageDescription>
<NDC11Code>00245-0823-04</NDC11Code>
<ProductNDC>0245-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0823-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0245-0823-30) </PackageDescription>
<NDC11Code>00245-0823-30</NDC11Code>
<ProductNDC>0245-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>17856-0823-1</NDCCode>
<PackageDescription>10 mL in 1 CUP (17856-0823-1) </PackageDescription>
<NDC11Code>17856-0823-01</NDC11Code>
<ProductNDC>17856-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074650</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is -(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C H N O S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is: N1101133. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C H N O . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is: 141843. alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor. Inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>17856-0823-5</NDCCode>
<PackageDescription>5 mL in 1 CUP (17856-0823-5) </PackageDescription>
<NDC11Code>17856-0823-05</NDC11Code>
<ProductNDC>17856-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074650</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160504</StartMarketingDatePackage>
<EndMarketingDatePackage>20190927</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration. Sulfamethoxazole is -(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C H N O S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is: N1101133. Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is C H N O . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is: 141843. alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor. Inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>21695-823-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-823-30)</PackageDescription>
<NDC11Code>21695-0823-30</NDC11Code>
<ProductNDC>21695-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076549</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ramipril capsules are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).</IndicationAndUsage>
<Description>Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Ramipril is supplied as hard shell capsules for oral administration containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10, D&C red #28, FD&C red #40 and yellow iron oxide, the 5 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains D&C red #28, FD&C blue #1, FD&C red #40 and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>23155-823-73</NDCCode>
<PackageDescription>8 TABLET in 1 BOTTLE (23155-823-73) </PackageDescription>
<NDC11Code>23155-0823-73</NDC11Code>
<ProductNDC>23155-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabergoline</ProprietaryName>
<NonProprietaryName>Cabergoline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076310</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CABERGOLINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.</IndicationAndUsage>
<Description>Cabergoline Tablets, USP contain Cabergoline USP, a dopamine receptor agonist. The chemical name for Cabergoline USP is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(di- methylamino)propyl]-3-ethylurea. Its molecular formula is C26H37N5O2, and its molecular weight is 451.62. The structural formula is as follows. Cabergoline USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water. Each tablet, for oral administration, contains 0.5 mg of Cabergoline USP. Inactive ingredients consist of citric acid, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>43063-823-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20) </PackageDescription>
<NDC11Code>43063-0823-20</NDC11Code>
<ProductNDC>43063-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065489</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) , 2 Acute Maxillary Sinusitis ( 1.2) , 3 Community-Acquired Pneumonia ( 1.3) , 4 Pharyngitis/Tonsillitis ( 1.4) , 5 Uncomplicated Skin and Skin Structure Infections ( 1.5) , 6 Acute Otitis Media in Pediatric Patients ( 1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) , 8 Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults ( 1.8) .</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid.</Description>
</NDC>
<NDC>
<NDCCode>43063-823-28</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28) </PackageDescription>
<NDC11Code>43063-0823-28</NDC11Code>
<ProductNDC>43063-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065489</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) , 2 Acute Maxillary Sinusitis ( 1.2) , 3 Community-Acquired Pneumonia ( 1.3) , 4 Pharyngitis/Tonsillitis ( 1.4) , 5 Uncomplicated Skin and Skin Structure Infections ( 1.5) , 6 Acute Otitis Media in Pediatric Patients ( 1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) , 8 Helicobacter pyloriInfection and Duodenal Ulcer Disease in Adults ( 1.8) .</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin USP is a white or almost white, crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin tablets, USP are available as immediate-release tablets. Each film-coated tablet contains 250 mg or 500 mg of clarithromycin USP and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, hypromellose, titanium dioxide, hydroxypropyl cellulose, iron oxide yellow, propylene glycol, vanillin, and sorbic acid.</Description>
</NDC>
<NDC>
<NDCCode>50268-823-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-823-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-823-11) </PackageDescription>
<NDC11Code>50268-0823-15</NDC11Code>
<ProductNDC>50268-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077670</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 112.0 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Ascorbic acid (in 25 mg, 50 mg and 100 mg tablets), D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance.</Description>
</NDC>
<NDC>
<NDCCode>50383-823-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-823-16) </PackageDescription>
<NDC11Code>50383-0823-16</NDC11Code>
<ProductNDC>50383-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074650</ApplicationNumber>
<LabelerName>Akorn Operating Company LLC</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>200; 40</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis jiroveci pneumonia. Traveler’s Diarrhea In Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim oral suspension is a synthetic antibacterial combination product available for oral administration, with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: alcohol 0.26%, methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), carboxymethylcellulose sodium, citric acid (anhydrous), glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, and sorbitol. The light purple, grape flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and artificial grape flavor. The pink, cherry flavored suspension contains the following additional inactive ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry flavor.</Description>
</NDC>
<NDC>
<NDCCode>58160-823-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58160-823-11) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03) </PackageDescription>
<NDC11Code>58160-0823-11</NDC11Code>
<ProductNDC>58160-823</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Shingrix</ProprietaryName>
<NonProprietaryName>Zoster Vaccine Recombinant, Adjuvanted</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125614</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): 1 in adults aged 50 years and older., 2 in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.</IndicationAndUsage>
<Description>SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) is a sterile injectable suspension for intramuscular use that contains recombinant varicella zoster virus gE antigen adjuvanted with AS01B. The vial and vial presentation is supplied as a vial of lyophilized recombinant varicella zoster virus surface gE antigen component (Lyophilized gE Antigen Component), which must be reconstituted at the time of use with the accompanying vial of AS01B (Adjuvant Suspension Component) to form SHINGRIX. The SHINGRIX prefilled syringe presentation does not require reconstitution. SHINGRIX is a sterile, opalescent, colorless to pale brownish liquid. The gE antigen is obtained by culturing genetically engineered Chinese Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal‑derived proteins. The gE protein is purified by several chromatographic steps and formulated with excipients. The AS01B adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) derived from Salmonella minnesota and QS‑21, a saponin purified from Quillaja saponaria Molina plant extract, and is combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate‑buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. Each 0.5‑mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS‑21. Each dose also contains 20 mg of sucrose, 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate (applicable to prefilled syringe presentation only), 0.160 mg of sodium dihydrogen phosphate anhydrous (applicable to vial and vial presentation only), 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. SHINGRIX does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (≤3.0%) and DNA (≤2.1 picograms) from the manufacturing process. In the vial and vial presentation, the vial stoppers are not made with natural rubber latex. In the prefilled syringe presentation, the tip cap and rubber plunger stopper are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>60505-0823-6</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (60505-0823-6) / 30 SPRAY, METERED in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>60505-0823-06</NDC11Code>
<ProductNDC>60505-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitonin Salmon</ProprietaryName>
<NonProprietaryName>Calcitonin Salmon</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20081209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076396</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>CALCITONIN SALMON</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[iU]/1</StrengthUnit>
<Pharm_Classes>Calcitonin [CS], Calcitonin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitonin Salmon (synthetic origin) Nasal Spray is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated (1.1). Limitations of Use: 1 Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis (1.2, 5.4), 2 Calcitonin salmon nasal spray has not been shown to increase bone mineral density in early postmenopausal women (1.2).</IndicationAndUsage>
<Description>Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin Salmon (synthetic origin) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula. It is provided in a 2 mL or 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 14 doses (2 mL fill) or 30 doses (3.7 mL fill). Active Ingredient: calcitonin salmon 2200 USP Calcitonin Salmon Units per mL (corresponding to 200 USP Calcitonin Salmon Units per 0.09 mL actuation). Inactive Ingredients: benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH), purified water and sodium chloride. The activity of calcitonin salmon nasal spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute of Biological Standards and Control, Holly Hill, London.</Description>
</NDC>
<NDC>
<NDCCode>62135-823-84</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (62135-823-84) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE</PackageDescription>
<NDC11Code>62135-0823-84</NDC11Code>
<ProductNDC>62135-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078202</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25H 34O 6and its molecular weight is 430.5. Its structural formula is:. Budesonide is a white or almost white, crystalline powder that is practically insoluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients citric acid, edetate disodium dihydrate, polysorbate 80, sodium chloride, sodium citrate, and water for injection. Two dose strengths are available in single-dose ampules: 0.25 mg and 0.5 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitroconditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration(2)].</Description>
</NDC>
<NDC>
<NDCCode>63323-823-20</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01) </PackageDescription>
<NDC11Code>63323-0823-20</NDC11Code>
<ProductNDC>63323-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ertapenem</ProprietaryName>
<NonProprietaryName>Ertapenem Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20191010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208790</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ERTAPENEM SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ertapenem for Injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: : 1 Complicated intra-abdominal infections. ( 1.1) , 2 Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2) , 3 Community-acquired pneumonia. ( 1.3) , 4 Complicated urinary tract infections including pyelonephritis. ( 1.4) , 5 Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections. ( 1.5) .</IndicationAndUsage>
<Description>Ertapenem for Injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for Injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo [3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.5. The empirical formula is C22H24N3O7SNa, and its structural formula is. Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for Injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration ( 2.7)] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6 mEq). Each vial of Ertapenem for Injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>67296-0823-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67296-0823-1) </PackageDescription>
<NDC11Code>67296-0823-01</NDC11Code>
<ProductNDC>67296-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Osteoarthritis (OA). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. [Chemical Structure]. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>67296-0823-5</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (67296-0823-5) </PackageDescription>
<NDC11Code>67296-0823-05</NDC11Code>
<ProductNDC>67296-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Osteoarthritis (OA). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. [Chemical Structure]. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>67296-0823-7</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (67296-0823-7) </PackageDescription>
<NDC11Code>67296-0823-07</NDC11Code>
<ProductNDC>67296-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Osteoarthritis (OA). Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA). Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course. Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. [Chemical Structure]. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>71610-823-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71610-823-30) </PackageDescription>
<NDC11Code>71610-0823-30</NDC11Code>
<ProductNDC>71610-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211685</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>71610-823-46</NDCCode>
<PackageDescription>56 CAPSULE in 1 BOTTLE (71610-823-46) </PackageDescription>
<NDC11Code>71610-0823-46</NDC11Code>
<ProductNDC>71610-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211685</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>71610-823-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71610-823-53) </PackageDescription>
<NDC11Code>71610-0823-53</NDC11Code>
<ProductNDC>71610-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211685</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>71610-823-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71610-823-60) </PackageDescription>
<NDC11Code>71610-0823-60</NDC11Code>
<ProductNDC>71610-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211685</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>71610-823-80</NDCCode>
<PackageDescription>180 CAPSULE in 1 BOTTLE (71610-823-80) </PackageDescription>
<NDC11Code>71610-0823-80</NDC11Code>
<ProductNDC>71610-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211685</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240422</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23 g/mol. The chemical structure of pregabalin is:. Pregabalin, USP is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) shells contain iron oxide red. The imprinting ink contains iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>50090-0001-0</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (50090-0001-0) / 1 SUPPOSITORY in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-0001-00</NDC11Code>
<ProductNDC>50090-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<ProprietaryNameSuffix>For Children</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20101214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070607</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily : 1 reduces fever , 2 relieves minor aches, pains, and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-0002-0</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (50090-0002-0) </PackageDescription>
<NDC11Code>50090-0002-00</NDC11Code>
<ProductNDC>50090-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharbest Regular Strength Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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