{
"NDC": [
{
"NDCCode": "70710-2093-4",
"PackageDescription": "1 KIT in 1 KIT (70710-2093-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) ",
"NDC11Code": "70710-2093-04",
"ProductNDC": "70710-2093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beizray",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "KIT",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218711",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "BEIZRAY is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.89. It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment. The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin."
},
{
"NDCCode": "36987-2093-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-2093-4)",
"NDC11Code": "36987-2093-04",
"ProductNDC": "36987-2093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saccharomyces Cerevisiae",
"NonProprietaryName": "Saccharomyces Cerevisiae",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SACCHAROMYCES CEREVISIAE",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2093-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-2093-4) ",
"NDC11Code": "37662-2093-04",
"ProductNDC": "37662-2093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Silicea",
"NonProprietaryName": "Silicea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SILICON DIOXIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221214",
"SamplePackage": "N"
},
{
"NDCCode": "50090-2093-4",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-2093-4) ",
"NDC11Code": "50090-2093-04",
"ProductNDC": "50090-2093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulindac",
"NonProprietaryName": "Sulindac",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072051",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULINDAC",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151012",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis*, 3 Ankylosing spondylitis, 4 Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), 5 Acute gouty arthritis.",
"Description": "Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p-(methylsulfinyl)phenyl]methylene]-1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac tablets are available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Following absorption, sulindac undergoes two major biotransformations — reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are."
},
{
"NDCCode": "61995-2093-4",
"PackageDescription": "113 g in 1 TUBE (61995-2093-4) ",
"NDC11Code": "61995-2093-04",
"ProductNDC": "61995-2093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alba Botanica Pure Lavender Sunscreen Spf45",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene, Octyl Salicylate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170809",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Hain Celestial Group, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 10",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases."
},
{
"NDCCode": "54868-2093-0",
"PackageDescription": "355 mL in 1 BOTTLE (54868-2093-0)",
"NDC11Code": "54868-2093-00",
"ProductNDC": "54868-2093",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maalox Antacid",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Simethicone",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20061212",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "200; 200; 20",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for the relief of: 1 acid indigestion , 2 heartburn , 3 sour stomach , 4 upset stomach associated with these symptoms , 5 pressure and bloating commonly referred to as gas."
},
{
"NDCCode": "70710-1006-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1006-4) > 10 TABLET in 1 BLISTER PACK (70710-1006-2) ",
"NDC11Code": "70710-1006-04",
"ProductNDC": "70710-1006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Misoprostol",
"NonProprietaryName": "Misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210201",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MISOPROSTOL",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200114",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1007-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1007-4) > 10 TABLET in 1 BLISTER PACK (70710-1007-2) ",
"NDC11Code": "70710-1007-04",
"ProductNDC": "70710-1007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Misoprostol",
"NonProprietaryName": "Misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210201",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MISOPROSTOL",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200114",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1014-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1014-4) / 10 TABLET in 1 BLISTER PACK (70710-1014-2) ",
"NDC11Code": "70710-1014-04",
"ProductNDC": "70710-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210189",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190222",
"SamplePackage": "Y",
"IndicationAndUsage": "Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "70710-1015-8",
"PackageDescription": "4 VIAL in 1 CARTON (70710-1015-8) / 30 mL in 1 VIAL (70710-1015-1) ",
"NDC11Code": "70710-1015-08",
"ProductNDC": "70710-1015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208166",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190117",
"SamplePackage": "N",
"IndicationAndUsage": "Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).",
"Description": "Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula. Acetylcysteine injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine injection contains the following inactive ingredients: 0.5 mg/mL edetate disodium, sodium hydroxide (used for pH adjustment), and Water for Injection, USP."
},
{
"NDCCode": "70710-1019-4",
"PackageDescription": "4 BOTTLE in 1 CARTON (70710-1019-4) / 25 TABLET in 1 BOTTLE",
"NDC11Code": "70710-1019-04",
"ProductNDC": "70710-1019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210153",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets, USP are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablets that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, colloidal silicon dioxide, glyceryl monostearate, lactose monohydrate and pregelatinized starch (botanical source: maize). Nitroglycerin, USP is white crystalline powder. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.1."
},
{
"NDCCode": "70710-1022-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1022-4) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1022-04",
"ProductNDC": "70710-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1023-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1023-4) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1023-04",
"ProductNDC": "70710-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1025-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1025-4) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1025-04",
"ProductNDC": "70710-1025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211568",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "70710-1053-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1053-4) > 10 TABLET in 1 BLISTER PACK (70710-1053-2) ",
"NDC11Code": "70710-1053-04",
"ProductNDC": "70710-1053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170815",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1054-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1054-4) > 10 TABLET in 1 BLISTER PACK (70710-1054-2) ",
"NDC11Code": "70710-1054-04",
"ProductNDC": "70710-1054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170815",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1104-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1104-4) > 10 TABLET in 1 BLISTER PACK (70710-1104-2) ",
"NDC11Code": "70710-1104-04",
"ProductNDC": "70710-1104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208187",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1105-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1105-4) > 10 TABLET in 1 BLISTER PACK (70710-1105-2) ",
"NDC11Code": "70710-1105-04",
"ProductNDC": "70710-1105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208187",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180913",
"SamplePackage": "N"
},
{
"NDCCode": "70710-1111-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1111-4) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1111-04",
"ProductNDC": "70710-1111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208622",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170427",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).",
"Description": "Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide."
},
{
"NDCCode": "70710-1112-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1112-4) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1112-04",
"ProductNDC": "70710-1112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208622",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170427",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).",
"Description": "Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide."
},
{
"NDCCode": "70710-1113-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1113-4) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "70710-1113-04",
"ProductNDC": "70710-1113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208622",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170427",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).",
"Description": "Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide."
},
{
"NDCCode": "70710-1129-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1129-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1129-2) ",
"NDC11Code": "70710-1129-04",
"ProductNDC": "70710-1129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213368",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200127",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "70710-1130-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1130-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1130-2) ",
"NDC11Code": "70710-1130-04",
"ProductNDC": "70710-1130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213368",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200127",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "70710-1131-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1131-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1131-2) ",
"NDC11Code": "70710-1131-04",
"ProductNDC": "70710-1131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213368",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200127",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "70710-1132-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1132-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1132-2) ",
"NDC11Code": "70710-1132-04",
"ProductNDC": "70710-1132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213368",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200127",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "70710-1133-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1133-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1133-2) ",
"NDC11Code": "70710-1133-04",
"ProductNDC": "70710-1133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213368",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200127",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "70710-1137-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1137-4) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "70710-1137-04",
"ProductNDC": "70710-1137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208963",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170406",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70710-1138-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1138-4) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "70710-1138-04",
"ProductNDC": "70710-1138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208963",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170406",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70710-1140-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1140-4) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "70710-1140-04",
"ProductNDC": "70710-1140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208963",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170406",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70710-1161-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1161-4) / 10 TABLET in 1 BLISTER PACK (70710-1161-2) ",
"NDC11Code": "70710-1161-04",
"ProductNDC": "70710-1161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213957",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201029",
"SamplePackage": "N",
"IndicationAndUsage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white to slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Inactive ingredients for the tablets are: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide and sodium starch glycolate. In addition, the 12.5 mg tablet contains FD&C Blue # 1 Aluminum Lake; and the 25 mg tablet contains D&C Yellow # 10 Aluminum Lake and FD&C Yellow # 6 Aluminum Lake. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70710-2093-4</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70710-2093-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) </PackageDescription>
<NDC11Code>70710-2093-04</NDC11Code>
<ProductNDC>70710-2093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beizray</ProprietaryName>
<NonProprietaryName>Docetaxel</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218711</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BEIZRAY is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.89. It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment. The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin.</Description>
</NDC>
<NDC>
<NDCCode>36987-2093-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2093-4)</PackageDescription>
<NDC11Code>36987-2093-04</NDC11Code>
<ProductNDC>36987-2093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Saccharomyces Cerevisiae</ProprietaryName>
<NonProprietaryName>Saccharomyces Cerevisiae</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SACCHAROMYCES CEREVISIAE</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2093-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-2093-4) </PackageDescription>
<NDC11Code>37662-2093-04</NDC11Code>
<ProductNDC>37662-2093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Silicea</ProprietaryName>
<NonProprietaryName>Silicea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SILICON DIOXIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-2093-4</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-2093-4) </PackageDescription>
<NDC11Code>50090-2093-04</NDC11Code>
<ProductNDC>50090-2093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulindac</ProprietaryName>
<NonProprietaryName>Sulindac</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072051</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULINDAC</SubstanceName>
<StrengthNumber>200</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: 1 Osteoarthritis, 2 Rheumatoid arthritis*, 3 Ankylosing spondylitis, 4 Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p-(methylsulfinyl)phenyl]methylene]-1 H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20H 17FO 3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac tablets are available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Following absorption, sulindac undergoes two major biotransformations — reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are.</Description>
</NDC>
<NDC>
<NDCCode>61995-2093-4</NDCCode>
<PackageDescription>113 g in 1 TUBE (61995-2093-4) </PackageDescription>
<NDC11Code>61995-2093-04</NDC11Code>
<ProductNDC>61995-2093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alba Botanica Pure Lavender Sunscreen Spf45</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Octyl Salicylate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170809</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>The Hain Celestial Group, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10; 5; 10</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-2093-0</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (54868-2093-0)</PackageDescription>
<NDC11Code>54868-2093-00</NDC11Code>
<ProductNDC>54868-2093</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maalox Antacid</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Simethicone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>200; 200; 20</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for the relief of: 1 acid indigestion , 2 heartburn , 3 sour stomach , 4 upset stomach associated with these symptoms , 5 pressure and bloating commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70710-1006-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1006-4) > 10 TABLET in 1 BLISTER PACK (70710-1006-2) </PackageDescription>
<NDC11Code>70710-1006-04</NDC11Code>
<ProductNDC>70710-1006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Misoprostol</ProprietaryName>
<NonProprietaryName>Misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210201</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>MISOPROSTOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1007-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1007-4) > 10 TABLET in 1 BLISTER PACK (70710-1007-2) </PackageDescription>
<NDC11Code>70710-1007-04</NDC11Code>
<ProductNDC>70710-1007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Misoprostol</ProprietaryName>
<NonProprietaryName>Misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210201</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>MISOPROSTOL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1014-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1014-4) / 10 TABLET in 1 BLISTER PACK (70710-1014-2) </PackageDescription>
<NDC11Code>70710-1014-04</NDC11Code>
<ProductNDC>70710-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210189</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C31H46O2 and its structural formula is. Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>70710-1015-8</NDCCode>
<PackageDescription>4 VIAL in 1 CARTON (70710-1015-8) / 30 mL in 1 VIAL (70710-1015-1) </PackageDescription>
<NDC11Code>70710-1015-08</NDC11Code>
<ProductNDC>70710-1015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetylcysteine</ProprietaryName>
<NonProprietaryName>Acetylcysteine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208166</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).</IndicationAndUsage>
<Description>Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula. Acetylcysteine injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine injection contains the following inactive ingredients: 0.5 mg/mL edetate disodium, sodium hydroxide (used for pH adjustment), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-1019-4</NDCCode>
<PackageDescription>4 BOTTLE in 1 CARTON (70710-1019-4) / 25 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70710-1019-04</NDC11Code>
<ProductNDC>70710-1019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210153</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets, USP are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablets that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, colloidal silicon dioxide, glyceryl monostearate, lactose monohydrate and pregelatinized starch (botanical source: maize). Nitroglycerin, USP is white crystalline powder. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.1.</Description>
</NDC>
<NDC>
<NDCCode>70710-1022-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1022-4) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1022-04</NDC11Code>
<ProductNDC>70710-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1023-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1023-4) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1023-04</NDC11Code>
<ProductNDC>70710-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1025-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1025-4) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1025-04</NDC11Code>
<ProductNDC>70710-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211568</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of isotretinoin capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15-week to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin, USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44. It is soluble in chloroform, sparingly soluble in alcohol, in isopropyl alcohol, and polyethylene glycol 400, practically insoluble in water. The structural formula is. Isotretinoin, USP a retinoid, is available as isotretinoin capsules USP in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each isotretinoin capsule, USP intended for oral administration contains 10 mg, 20 mg, 30 mg and 40 mg of isotretinoin, USP. In addition, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, ferrosoferric oxide, ferric oxide red, ferric oxide yellow, gelatin, glycerin, hydrogenated soybean oil, purified water, soybean oil, titanium dioxide and white wax. Each capsule shell is printed with black pharmaceutical ink which contains the following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>70710-1053-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1053-4) > 10 TABLET in 1 BLISTER PACK (70710-1053-2) </PackageDescription>
<NDC11Code>70710-1053-04</NDC11Code>
<ProductNDC>70710-1053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1054-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1054-4) > 10 TABLET in 1 BLISTER PACK (70710-1054-2) </PackageDescription>
<NDC11Code>70710-1054-04</NDC11Code>
<ProductNDC>70710-1054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1104-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1104-4) > 10 TABLET in 1 BLISTER PACK (70710-1104-2) </PackageDescription>
<NDC11Code>70710-1104-04</NDC11Code>
<ProductNDC>70710-1104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208187</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1105-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1105-4) > 10 TABLET in 1 BLISTER PACK (70710-1105-2) </PackageDescription>
<NDC11Code>70710-1105-04</NDC11Code>
<ProductNDC>70710-1105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208187</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70710-1111-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1111-4) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1111-04</NDC11Code>
<ProductNDC>70710-1111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208622</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1112-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1112-4) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1112-04</NDC11Code>
<ProductNDC>70710-1112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208622</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1113-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1113-4) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1113-04</NDC11Code>
<ProductNDC>70710-1113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208622</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. (1).</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1129-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1129-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1129-2) </PackageDescription>
<NDC11Code>70710-1129-04</NDC11Code>
<ProductNDC>70710-1129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213368</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1130-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1130-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1130-2) </PackageDescription>
<NDC11Code>70710-1130-04</NDC11Code>
<ProductNDC>70710-1130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213368</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1131-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1131-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1131-2) </PackageDescription>
<NDC11Code>70710-1131-04</NDC11Code>
<ProductNDC>70710-1131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213368</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1132-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1132-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1132-2) </PackageDescription>
<NDC11Code>70710-1132-04</NDC11Code>
<ProductNDC>70710-1132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213368</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1133-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1133-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1133-2) </PackageDescription>
<NDC11Code>70710-1133-04</NDC11Code>
<ProductNDC>70710-1133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213368</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients:. Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1137-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1137-4) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1137-04</NDC11Code>
<ProductNDC>70710-1137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208963</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-1138-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1138-4) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1138-04</NDC11Code>
<ProductNDC>70710-1138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208963</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-1140-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1140-4) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70710-1140-04</NDC11Code>
<ProductNDC>70710-1140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208963</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 Vaginal candidiasis (vaginal yeast infections due to Candida)., 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia., 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole USP is a white or almost white crystalline powder which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropanol and in chloroform, slightly soluble in water, very slightly soluble in toluene. Each fluconazole tablet, USP intended for oral administration contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red no. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70710-1161-4</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (70710-1161-4) / 10 TABLET in 1 BLISTER PACK (70710-1161-2) </PackageDescription>
<NDC11Code>70710-1161-04</NDC11Code>
<ProductNDC>70710-1161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213957</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white to slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride, USP is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Inactive ingredients for the tablets are: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide and sodium starch glycolate. In addition, the 12.5 mg tablet contains FD&C Blue # 1 Aluminum Lake; and the 25 mg tablet contains D&C Yellow # 10 Aluminum Lake and FD&C Yellow # 6 Aluminum Lake. Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.</Description>
</NDC>
</NDCList>