{
"NDC": [
{
"NDCCode": "51079-457-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-457-20) > 1 TABLET in 1 BLISTER PACK (51079-457-01)",
"NDC11Code": "51079-0457-20",
"ProductNDC": "51079-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077923",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-02-07"
},
{
"NDCCode": "21749-457-20",
"PackageDescription": "2000 mL in 1 PACKAGE (21749-457-20) ",
"NDC11Code": "21749-0457-20",
"ProductNDC": "21749-457",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gojo Pcmx E-2 Sanitizing Ltn Sp",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".003",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190225",
"SamplePackage": "N",
"IndicationAndUsage": "Handwash to help decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "43063-457-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20) ",
"NDC11Code": "43063-0457-20",
"ProductNDC": "43063-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201043",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221102",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4). : 1 Pneumonia: Nosocomial ( 1.1) and Community Acquired ( 1.2, 1.3) , 2 Skin and Skin Structure Infections (SSSI): Complicated ( 1.4) and Uncomplicated ( 1.5) , 3 Chronic bacterial prostatitis ( 1.6) , 4 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7) , 5 Plague in adult and pediatric patients ( 1.8) , 6 Urinary Tract Infections (UTI): Complicated ( 1.9, 1.10) and Uncomplicated ( 1.12) , 7 Acute Pyelonephritis ( 1.11) , 8 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) , 9 Acute Bacterial Sinusitis ( 1.14) .",
"Description": "Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C 18H 20FN 3O 4 ½ H 2O and the molecular weight is 370.38. Levofloxacin USP is a pale or bright yellow, crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely solublein this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely solublein this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitrochelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg, 500 mg and 750 mg (as expressed in the anhydrous form): croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. In addition 250 mg contains iron oxide red and 500 mg contains iron oxide red and iron oxide yellow. Meets USP dissolution test 4."
},
{
"NDCCode": "51655-457-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (51655-457-20) ",
"NDC11Code": "51655-0457-20",
"ProductNDC": "51655-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074140",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230703",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets are also indicated for: the relief of signs and symptoms of:. tendonitis bursitis acute gout the management of: pain primary dysmenorrhea.",
"Description": "Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as white to off-white tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6 methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone."
},
{
"NDCCode": "52125-457-03",
"PackageDescription": "20 CAPSULE in 1 VIAL (52125-457-03)",
"NDC11Code": "52125-0457-03",
"ProductNDC": "52125-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062676",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "55289-457-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20) ",
"NDC11Code": "55289-0457-20",
"ProductNDC": "55289-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"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": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110505",
"SamplePackage": "N"
},
{
"NDCCode": "67457-457-20",
"PackageDescription": "10 VIAL in 1 CARTON (67457-457-20) / 20 mL in 1 VIAL (67457-457-00) ",
"NDC11Code": "67457-0457-20",
"ProductNDC": "67457-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078641",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080626",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: : 1 1.Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. , 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. , 3 3.Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. , 4 4.Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). , 5 5.Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).",
"Description": "The active ingredient in Famotidine Injection, USP is a histamine H2-receptor antagonist. Famotidine, USP is N′-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Famotidine, USP is a white to pale yellowish white crystalline powder compound that is freely soluble in dimethylformamide and glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. Famotidine Injection, USP is supplied as a sterile concentrated solution for intravenous injection. Each mL of the single dose solution contains 10 mg of famotidine, USP and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, and Water for Injection q.s. 1 mL. The multidose injection also contains benzyl alcohol 0.9% added as preservative."
},
{
"NDCCode": "76420-457-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (76420-457-20) ",
"NDC11Code": "76420-0457-20",
"ProductNDC": "76420-457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204590",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250813",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 50 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red#40 Aluminum Lake- E129. The imprinting ink of capsule shell of the 100 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and FD&C Blue#2 Aluminum Lake-E132. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide. The imprinting ink of capsule shell of the 400 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide, FD&C Blue#1 Aluminum Lake- E133 and FD&C Yellow#5 Aluminum Lake-E102."
},
{
"NDCCode": "51079-007-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-007-20) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (51079-007-01) ",
"NDC11Code": "51079-0007-20",
"ProductNDC": "51079-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075876",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20030901",
"SamplePackage": "N"
},
{
"NDCCode": "51079-023-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-023-20) / 1 TABLET in 1 BLISTER PACK (51079-023-01) ",
"NDC11Code": "51079-0023-20",
"ProductNDC": "51079-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076698",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050415",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .",
"Description": "Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51079-024-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-024-20) / 1 TABLET in 1 BLISTER PACK (51079-024-01) ",
"NDC11Code": "51079-0024-20",
"ProductNDC": "51079-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076698",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050201",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .",
"Description": "Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51079-027-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-027-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01)",
"NDC11Code": "51079-0027-20",
"ProductNDC": "51079-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinidine Gluconate",
"NonProprietaryName": "Quinidine Gluconate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089338",
"LabelerName": "UDL Laboratories, Inc.",
"SubstanceName": "QUINIDINE GLUCONATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-04-10"
},
{
"NDCCode": "51079-028-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-028-20) / 1 CAPSULE in 1 BLISTER PACK (51079-028-01) ",
"NDC11Code": "51079-0028-20",
"ProductNDC": "51079-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090596",
"LabelerName": "MylanInstitutional Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101101",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. ( 1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
},
{
"NDCCode": "51079-034-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-034-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-034-01)",
"NDC11Code": "51079-0034-20",
"ProductNDC": "51079-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076276",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "51079-035-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-035-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-035-01)",
"NDC11Code": "51079-0035-20",
"ProductNDC": "51079-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076276",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "51079-047-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-047-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-047-01) ",
"NDC11Code": "51079-0047-20",
"ProductNDC": "51079-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090942",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110323",
"SamplePackage": "N"
},
{
"NDCCode": "51079-051-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-051-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-051-01) ",
"NDC11Code": "51079-0051-20",
"ProductNDC": "51079-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090970",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110223",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium salt of 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-Pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.36. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.55 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.10 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablets contain the following inactive ingredients: anhydrous sodium carbonate, calcium stearate, crospovidone, hypromellose, mannitol, methacrylic acid copolymer type A, povidone, propylene glycol, titanium dioxide, triethyl citrate and yellow iron oxide. The black imprinting ink contains black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
},
{
"NDCCode": "51079-058-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-058-20) / 1 TABLET in 1 BLISTER PACK (51079-058-01) ",
"NDC11Code": "51079-0058-20",
"ProductNDC": "51079-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086831",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980612",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake."
},
{
"NDCCode": "51079-067-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-067-20) > 1 TABLET in 1 BLISTER PACK (51079-067-01)",
"NDC11Code": "51079-0067-20",
"ProductNDC": "51079-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085762",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
"StrengthNumber": ".025; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2015-07-31"
},
{
"NDCCode": "51079-072-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-072-20) / 1 TABLET in 1 BLISTER PACK (51079-072-01) ",
"NDC11Code": "51079-0072-20",
"ProductNDC": "51079-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970206",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970206",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "51079-073-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-073-20) / 1 TABLET in 1 BLISTER PACK (51079-073-01) ",
"NDC11Code": "51079-0073-20",
"ProductNDC": "51079-073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970206",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970206",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "51079-074-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-074-20) / 1 TABLET in 1 BLISTER PACK (51079-074-01) ",
"NDC11Code": "51079-0074-20",
"ProductNDC": "51079-074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089097",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071226",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "51079-075-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-075-20) / 1 TABLET in 1 BLISTER PACK (51079-075-01) ",
"NDC11Code": "51079-0075-20",
"ProductNDC": "51079-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088467",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071226",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "51079-076-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-076-20) / 1 TABLET in 1 BLISTER PACK (51079-076-01) ",
"NDC11Code": "51079-0076-20",
"ProductNDC": "51079-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088468",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071226",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "51079-077-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-077-20) > 1 CAPSULE in 1 BLISTER PACK (51079-077-01) ",
"NDC11Code": "51079-0077-20",
"ProductNDC": "51079-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071126",
"EndMarketingDate": "20210430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088496",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071126",
"EndMarketingDatePackage": "20210430",
"SamplePackage": "N"
},
{
"NDCCode": "51079-078-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-078-20) > 1 CAPSULE in 1 BLISTER PACK (51079-078-01) ",
"NDC11Code": "51079-0078-20",
"ProductNDC": "51079-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071126",
"EndMarketingDate": "20210831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088487",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071126",
"EndMarketingDatePackage": "20210831",
"SamplePackage": "N"
},
{
"NDCCode": "51079-083-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01) ",
"NDC11Code": "51079-0083-20",
"ProductNDC": "51079-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoniazid",
"NonProprietaryName": "Isoniazid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940609",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080937",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ISONIAZID",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19940609",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.",
"Description": "Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C 6H 7N 3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light."
},
{
"NDCCode": "51079-086-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-086-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-086-01) ",
"NDC11Code": "51079-0086-20",
"ProductNDC": "51079-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076122",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin."
},
{
"NDCCode": "51079-087-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-087-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-087-01) ",
"NDC11Code": "51079-0087-20",
"ProductNDC": "51079-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076122",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin."
},
{
"NDCCode": "51079-088-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-088-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01) ",
"NDC11Code": "51079-0088-20",
"ProductNDC": "51079-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076122",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51079-457-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-457-20) > 1 TABLET in 1 BLISTER PACK (51079-457-01)</PackageDescription>
<NDC11Code>51079-0457-20</NDC11Code>
<ProductNDC>51079-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077923</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>21749-457-20</NDCCode>
<PackageDescription>2000 mL in 1 PACKAGE (21749-457-20) </PackageDescription>
<NDC11Code>21749-0457-20</NDC11Code>
<ProductNDC>21749-457</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gojo Pcmx E-2 Sanitizing Ltn Sp</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.003</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Handwash to help decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-457-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20) </PackageDescription>
<NDC11Code>43063-0457-20</NDC11Code>
<ProductNDC>43063-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201043</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1, 12.4). : 1 Pneumonia: Nosocomial ( 1.1) and Community Acquired ( 1.2, 1.3) , 2 Skin and Skin Structure Infections (SSSI): Complicated ( 1.4) and Uncomplicated ( 1.5) , 3 Chronic bacterial prostatitis ( 1.6) , 4 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7) , 5 Plague in adult and pediatric patients ( 1.8) , 6 Urinary Tract Infections (UTI): Complicated ( 1.9, 1.10) and Uncomplicated ( 1.12) , 7 Acute Pyelonephritis ( 1.11) , 8 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) , 9 Acute Bacterial Sinusitis ( 1.14) .</IndicationAndUsage>
<Description>Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The molecular formula is C 18H 20FN 3O 4 ½ H 2O and the molecular weight is 370.38. Levofloxacin USP is a pale or bright yellow, crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin USP is essentially constant (approximately 100 mg/mL). Levofloxacin USP is considered soluble to freely solublein this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely solublein this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin USP has the potential to form stable coordination compounds with many metal ions. This in vitrochelation potential has the following formation order: Al +3>Cu +2>Zn +2>Mg +2>Ca +2. Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg, 500 mg and 750 mg (as expressed in the anhydrous form): croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. In addition 250 mg contains iron oxide red and 500 mg contains iron oxide red and iron oxide yellow. Meets USP dissolution test 4.</Description>
</NDC>
<NDC>
<NDCCode>51655-457-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (51655-457-20) </PackageDescription>
<NDC11Code>51655-0457-20</NDC11Code>
<ProductNDC>51655-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074140</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis. Naproxen tablets are also indicated for: the relief of signs and symptoms of:. tendonitis bursitis acute gout the management of: pain primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen tablets are available as white to off-white tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6 methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14H 13NaO 3. Naproxen and naproxen sodium have the following structures, respectively:. Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>52125-457-03</NDCCode>
<PackageDescription>20 CAPSULE in 1 VIAL (52125-457-03)</PackageDescription>
<NDC11Code>52125-0457-03</NDC11Code>
<ProductNDC>52125-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062676</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>55289-457-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20) </PackageDescription>
<NDC11Code>55289-0457-20</NDC11Code>
<ProductNDC>55289-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>400; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</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>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-457-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-457-20) / 20 mL in 1 VIAL (67457-457-00) </PackageDescription>
<NDC11Code>67457-0457-20</NDC11Code>
<ProductNDC>67457-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078641</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: : 1 1.Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. , 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. , 3 3.Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. , 4 4.Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies). , 5 5.Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).</IndicationAndUsage>
<Description>The active ingredient in Famotidine Injection, USP is a histamine H2-receptor antagonist. Famotidine, USP is N′-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is. Famotidine, USP is a white to pale yellowish white crystalline powder compound that is freely soluble in dimethylformamide and glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. Famotidine Injection, USP is supplied as a sterile concentrated solution for intravenous injection. Each mL of the single dose solution contains 10 mg of famotidine, USP and the following inactive ingredients: L-aspartic acid 4 mg, mannitol 20 mg, and Water for Injection q.s. 1 mL. The multidose injection also contains benzyl alcohol 0.9% added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>76420-457-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (76420-457-20) </PackageDescription>
<NDC11Code>76420-0457-20</NDC11Code>
<ProductNDC>76420-457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204590</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>400</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>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide. The imprinting ink of capsule shell of the 50 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red#40 Aluminum Lake- E129. The imprinting ink of capsule shell of the 100 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and FD&C Blue#2 Aluminum Lake-E132. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide. The imprinting ink of capsule shell of the 400 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide, FD&C Blue#1 Aluminum Lake- E133 and FD&C Yellow#5 Aluminum Lake-E102.</Description>
</NDC>
<NDC>
<NDCCode>51079-007-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-007-20) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (51079-007-01) </PackageDescription>
<NDC11Code>51079-0007-20</NDC11Code>
<ProductNDC>51079-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075876</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-023-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-023-20) / 1 TABLET in 1 BLISTER PACK (51079-023-01) </PackageDescription>
<NDC11Code>51079-0023-20</NDC11Code>
<ProductNDC>51079-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076698</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .</IndicationAndUsage>
<Description>Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51079-024-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-024-20) / 1 TABLET in 1 BLISTER PACK (51079-024-01) </PackageDescription>
<NDC11Code>51079-0024-20</NDC11Code>
<ProductNDC>51079-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076698</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .</IndicationAndUsage>
<Description>Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51079-027-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-027-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01)</PackageDescription>
<NDC11Code>51079-0027-20</NDC11Code>
<ProductNDC>51079-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinidine Gluconate</ProprietaryName>
<NonProprietaryName>Quinidine Gluconate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089338</ApplicationNumber>
<LabelerName>UDL Laboratories, Inc.</LabelerName>
<SubstanceName>QUINIDINE GLUCONATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-028-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-028-20) / 1 CAPSULE in 1 BLISTER PACK (51079-028-01) </PackageDescription>
<NDC11Code>51079-0028-20</NDC11Code>
<ProductNDC>51079-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090596</ApplicationNumber>
<LabelerName>MylanInstitutional Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. ( 1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>51079-034-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-034-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-034-01)</PackageDescription>
<NDC11Code>51079-0034-20</NDC11Code>
<ProductNDC>51079-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076276</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-035-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-035-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-035-01)</PackageDescription>
<NDC11Code>51079-0035-20</NDC11Code>
<ProductNDC>51079-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076276</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-047-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-047-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-047-01) </PackageDescription>
<NDC11Code>51079-0047-20</NDC11Code>
<ProductNDC>51079-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090942</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-051-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-051-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-051-01) </PackageDescription>
<NDC11Code>51079-0051-20</NDC11Code>
<ProductNDC>51079-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090970</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium salt of 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-Pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.36. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.55 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.10 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablets contain the following inactive ingredients: anhydrous sodium carbonate, calcium stearate, crospovidone, hypromellose, mannitol, methacrylic acid copolymer type A, povidone, propylene glycol, titanium dioxide, triethyl citrate and yellow iron oxide. The black imprinting ink contains black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>51079-058-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-058-20) / 1 TABLET in 1 BLISTER PACK (51079-058-01) </PackageDescription>
<NDC11Code>51079-0058-20</NDC11Code>
<ProductNDC>51079-058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086831</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>51079-067-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-067-20) > 1 TABLET in 1 BLISTER PACK (51079-067-01)</PackageDescription>
<NDC11Code>51079-0067-20</NDC11Code>
<ProductNDC>51079-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085762</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.025; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-07-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-072-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-072-20) / 1 TABLET in 1 BLISTER PACK (51079-072-01) </PackageDescription>
<NDC11Code>51079-0072-20</NDC11Code>
<ProductNDC>51079-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970206</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970206</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>51079-073-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-073-20) / 1 TABLET in 1 BLISTER PACK (51079-073-01) </PackageDescription>
<NDC11Code>51079-0073-20</NDC11Code>
<ProductNDC>51079-073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970206</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970206</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>51079-074-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-074-20) / 1 TABLET in 1 BLISTER PACK (51079-074-01) </PackageDescription>
<NDC11Code>51079-0074-20</NDC11Code>
<ProductNDC>51079-074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089097</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>51079-075-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-075-20) / 1 TABLET in 1 BLISTER PACK (51079-075-01) </PackageDescription>
<NDC11Code>51079-0075-20</NDC11Code>
<ProductNDC>51079-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088467</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>51079-076-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-076-20) / 1 TABLET in 1 BLISTER PACK (51079-076-01) </PackageDescription>
<NDC11Code>51079-0076-20</NDC11Code>
<ProductNDC>51079-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088468</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>51079-077-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-077-20) > 1 CAPSULE in 1 BLISTER PACK (51079-077-01) </PackageDescription>
<NDC11Code>51079-0077-20</NDC11Code>
<ProductNDC>51079-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071126</StartMarketingDate>
<EndMarketingDate>20210430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088496</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071126</StartMarketingDatePackage>
<EndMarketingDatePackage>20210430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-078-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-078-20) > 1 CAPSULE in 1 BLISTER PACK (51079-078-01) </PackageDescription>
<NDC11Code>51079-0078-20</NDC11Code>
<ProductNDC>51079-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Pamoate</ProprietaryName>
<NonProprietaryName>Hydroxyzine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071126</StartMarketingDate>
<EndMarketingDate>20210831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088487</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>HYDROXYZINE PAMOATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071126</StartMarketingDatePackage>
<EndMarketingDatePackage>20210831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-083-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01) </PackageDescription>
<NDC11Code>51079-0083-20</NDC11Code>
<ProductNDC>51079-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoniazid</ProprietaryName>
<NonProprietaryName>Isoniazid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940609</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080937</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ISONIAZID</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19940609</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.</IndicationAndUsage>
<Description>Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C 6H 7N 3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light.</Description>
</NDC>
<NDC>
<NDCCode>51079-086-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-086-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-086-01) </PackageDescription>
<NDC11Code>51079-0086-20</NDC11Code>
<ProductNDC>51079-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076122</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>51079-087-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-087-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-087-01) </PackageDescription>
<NDC11Code>51079-0087-20</NDC11Code>
<ProductNDC>51079-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076122</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>51079-088-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-088-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01) </PackageDescription>
<NDC11Code>51079-0088-20</NDC11Code>
<ProductNDC>51079-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076122</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
</NDCList>