{
"NDC": [
{
"NDCCode": "75907-047-30",
"PackageDescription": "30 BLISTER PACK in 1 BOX (75907-047-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-047-81) ",
"NDC11Code": "75907-0047-30",
"ProductNDC": "75907-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065044",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids.",
"Description": "Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are oral formulations of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in cyclosporine capsules [MODIFIED] and cyclosporine oral solution, USP [MODIFIED], is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N, 4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). Each soft gelatin cyclosporine capsule, USP [Modified] for oral administration contains 25 mg or 100 mg of cyclosporine, USP. In addition, each capsule contains the following inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, gelatin, glycerin, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil, red iron oxide, shellac, sorbitol special 76% and titanium dioxide USP. Cyclosporine oral solution, USP [MODIFIED] contains 100 mg/mL of cyclosporine, USP. Inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil. The chemical structure of cyclosporine, USP (also known as cyclosporin A) is."
},
{
"NDCCode": "75907-005-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (75907-005-30) ",
"NDC11Code": "75907-0005-30",
"ProductNDC": "75907-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240315",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075389",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240315",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.",
"Description": "Amiodarone hydrochloride tablets, USP is an antiarrhythmic drug, available for oral administration as white tablets containing 100 mg of amiodarone hydrochloride, white, scored tablets containing 200 mg of amiodarone hydrochloride, and yellow, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present are lactose, starch, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, and D&C Yellow #10. Amiodarone is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]- 3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows. C25H29I2NO3 ∙ HCl Molecular Weight: 681.8. Amiodarone HCl is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "75907-007-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (75907-007-30) ",
"NDC11Code": "75907-0007-30",
"ProductNDC": "75907-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amiodarone Hydrochloride",
"NonProprietaryName": "Amiodarone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075389",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "AMIODARONE HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240315",
"SamplePackage": "N",
"IndicationAndUsage": "Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.",
"Description": "Amiodarone hydrochloride tablets, USP is an antiarrhythmic drug, available for oral administration as white tablets containing 100 mg of amiodarone hydrochloride, white, scored tablets containing 200 mg of amiodarone hydrochloride, and yellow, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present are lactose, starch, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, and D&C Yellow #10. Amiodarone is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]- 3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows. C25H29I2NO3 ∙ HCl Molecular Weight: 681.8. Amiodarone HCl is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "75907-048-30",
"PackageDescription": "30 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81) ",
"NDC11Code": "75907-0048-30",
"ProductNDC": "75907-048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065044",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids.",
"Description": "Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are oral formulations of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in cyclosporine capsules [MODIFIED] and cyclosporine oral solution, USP [MODIFIED], is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N, 4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). Each soft gelatin cyclosporine capsule, USP [Modified] for oral administration contains 25 mg or 100 mg of cyclosporine, USP. In addition, each capsule contains the following inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, gelatin, glycerin, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil, red iron oxide, shellac, sorbitol special 76% and titanium dioxide USP. Cyclosporine oral solution, USP [MODIFIED] contains 100 mg/mL of cyclosporine, USP. Inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil. The chemical structure of cyclosporine, USP (also known as cyclosporin A) is."
},
{
"NDCCode": "75907-053-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-053-30) ",
"NDC11Code": "75907-0053-30",
"ProductNDC": "75907-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride (la)",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol."
},
{
"NDCCode": "75907-059-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (75907-059-30) ",
"NDC11Code": "75907-0059-30",
"ProductNDC": "75907-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075797",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240822",
"SamplePackage": "N",
"IndicationAndUsage": "Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.",
"Description": "Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N,N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows. C32H37NO8 M.W. 563.62. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL."
},
{
"NDCCode": "75907-060-30",
"PackageDescription": "30 g in 1 BOTTLE, PLASTIC (75907-060-30) ",
"NDC11Code": "75907-0060-30",
"ProductNDC": "75907-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065203",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2024-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240528",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc."
},
{
"NDCCode": "75907-166-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (75907-166-30) ",
"NDC11Code": "75907-0166-30",
"ProductNDC": "75907-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metyrosine",
"NonProprietaryName": "Metyrosine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218620",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "METYROSINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "Metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: : 1 Preoperative preparation of patients for surgery , 2 Management of patients when surgery is contraindicated , 3 Chronic treatment of patients with malignant pheochromocytoma .",
"Description": "Metyrosine is (–)-α-methyl-L-tyrosine or (α-MPT). It has the following structural formula. Metyrosine USP is a white to off-white, crystalline compound of molecular weight 195.22. It is very slightly soluble in water, acetone, and methanol, and insoluble in chloroform and benzene. It is soluble in acidic aqueous solutions. It is also soluble in alkaline aqueous solutions but is subject to oxidative degradation under these conditions. Metyrosine is supplied as capsules for oral administration. Each capsule contains 250 mg metyrosine, USP. Inactive ingredients are colloidal silicon dioxide, FD&C Blue # 2, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains: black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 2."
},
{
"NDCCode": "75907-169-11",
"PackageDescription": "1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE",
"NDC11Code": "75907-0169-11",
"ProductNDC": "75907-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorouracil",
"NonProprietaryName": "Fluorouracil Cream, 0.5%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250706",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020985",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250706",
"SamplePackage": "N",
"IndicationAndUsage": "Fluorouracil cream, 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.",
"Description": "Fluorouracil cream, 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C 4H 3FN 2O 2. Fluorouracil has a molecular weight of 130.08. Fluorouracil cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge ®) composed of methyl methacrylate/glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, glycerin, methyl gluceth-20, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine."
},
{
"NDCCode": "75907-309-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (75907-309-30) ",
"NDC11Code": "75907-0309-30",
"ProductNDC": "75907-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218729",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14)].",
"Description": "Tranexamic acid tablets, USP are an antifibrinolytic drug administered orally. The chemical name is trans-4-aminomethylcyclohexanecarboxylic acid. The structural formula is. Tranexamic acid, USP is a white crystalline powder. It is freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in Alcohol. The molecular formula is C8H15N02 and the molecular weight is 157.2. Tranexamic acid tablets, USP are provided as a white to off white, oval, biconvex tablets debossed with “A 194” on one side and plain on the other side. The active ingredient in each tablet is 650 mg tranexamic acid, USP. The inactive ingredients contained in each tablet are: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized maize starch, stearic acid and talc. FDA approved dissolution test specifications differs from USP."
},
{
"NDCCode": "75907-310-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (75907-310-30) ",
"NDC11Code": "75907-0310-30",
"ProductNDC": "75907-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218712",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline hydrochloride capsules contain sertraline hydrochloride, USP a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.69 and has the following chemical name: (1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white or off-white crystalline powder that is sparingly soluble or slightly soluble in absolute alcohol; slightly soluble in water and in isopropanol; and slightly or very slightly soluble in acetone. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives. The Imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "75907-311-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (75907-311-30) ",
"NDC11Code": "75907-0311-30",
"ProductNDC": "75907-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218712",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline hydrochloride capsules contain sertraline hydrochloride, USP a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.69 and has the following chemical name: (1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white or off-white crystalline powder that is sparingly soluble or slightly soluble in absolute alcohol; slightly soluble in water and in isopropanol; and slightly or very slightly soluble in acetone. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives. The Imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "75907-327-11",
"PackageDescription": "1 KIT in 1 CARTON (75907-327-11) * 3 mL in 1 VIAL (75907-328-11) * 30 mL in 1 VIAL, SINGLE-DOSE (75907-326-11) ",
"NDC11Code": "75907-0327-11",
"ProductNDC": "75907-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carmustine",
"NonProprietaryName": "Carmustine",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213207",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following. - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.",
"Description": "The active ingredient in carmustine for injection USP, is a nitrosourea with the chemical name1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and poorly soluble in water. Carmustine for injection USP, is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine USP is. Carmustine for injection USP, is available in 100 mg single dose vials of lyophilized material.Sterile diluent for constitution of carmustine is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP."
},
{
"NDCCode": "75907-365-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (75907-365-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "75907-0365-30",
"ProductNDC": "75907-365",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"NonProprietaryName": "Simethicone Capsules Usp, 125 Mg",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20251226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260105",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas."
},
{
"NDCCode": "75907-405-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (75907-405-30) ",
"NDC11Code": "75907-0405-30",
"ProductNDC": "75907-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosutinib",
"NonProprietaryName": "Bosutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209624",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "BOSUTINIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260612",
"SamplePackage": "N",
"IndicationAndUsage": "Bosutinib tablets are indicated for the treatment of: 1 Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2)]. , 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)]. .",
"Description": "Bosutinib tablets contains bosutinib, a kinase inhibitor. The chemical name of bosutinib is 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-hydrate (1:2). Its chemical formula is C26H29Cl2N5O3.2H2O; its molecular weight is 566.48 Bosutinib has the following chemical structure. Bosutinib is a white to yellowish-tan powder. Bosutinib is soluble in dimethyl sulfoxide, sparingly soluble in acetone and practically insoluble in water. Bosutinib tablets are supplied for oral administration in a single strength of 400 mg, equivalent to 400 mg of bosutinib on an anhydrous basis. The tablets contain the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red."
},
{
"NDCCode": "75907-431-30",
"PackageDescription": "300 TABLET in 1 BOTTLE (75907-431-30) ",
"NDC11Code": "75907-0431-30",
"ProductNDC": "75907-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Diphenhydramine Hcl",
"NonProprietaryName": "Acetaminophen Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260925",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260925",
"SamplePackage": "N"
},
{
"NDCCode": "75907-434-30",
"PackageDescription": "300 TABLET in 1 BOTTLE (75907-434-30) ",
"NDC11Code": "75907-0434-30",
"ProductNDC": "75907-434",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210722",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. ■ runny nose. ■ sneezing. ■ itchy, watery eyes. ■ itching of the nose or throat."
},
{
"NDCCode": "10544-047-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-047-30)",
"NDC11Code": "10544-0047-30",
"ProductNDC": "10544-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040807",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine- 7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C yellow #6, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate."
},
{
"NDCCode": "11410-047-30",
"PackageDescription": "1 TUBE in 1 BOX (11410-047-30) / 30 mL in 1 TUBE",
"NDC11Code": "11410-0047-30",
"ProductNDC": "11410-047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactivplus Pore Clearing Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "for the management of acne."
},
{
"NDCCode": "11788-047-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (11788-047-03) ",
"NDC11Code": "11788-0047-03",
"ProductNDC": "11788-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217579",
"LabelerName": "AiPing Pharmaceutical, Inc",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230803",
"SamplePackage": "N",
"Description": "Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate."
},
{
"NDCCode": "13668-047-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-047-30) ",
"NDC11Code": "13668-0047-30",
"ProductNDC": "13668-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078947",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3."
},
{
"NDCCode": "16590-047-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-047-30)",
"NDC11Code": "16590-0047-30",
"ProductNDC": "16590-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040622",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Promethazine hydrochloride tablets are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each tablet for oral administration contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive ingredients present are colloidal silicon dioxide, disodium EDTA, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, saccharin sodium, and sodium starch glycolate. 12.5 mg also contains - FD&C Yellow No. 5 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake; 50 mg also contains - FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "31722-047-30",
"PackageDescription": "30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) ",
"NDC11Code": "31722-0047-30",
"ProductNDC": "31722-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sapropterin Dihydrochloride",
"NonProprietaryName": "Sapropterin Dihydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215420",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220818",
"SamplePackage": "N",
"IndicationAndUsage": "Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet.",
"Description": "Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is a white to pale yellow color powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula:. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate monohydrate and sucralose."
},
{
"NDCCode": "33342-047-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-047-07) ",
"NDC11Code": "33342-0047-07",
"ProductNDC": "33342-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan",
"NonProprietaryName": "Irbesartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202254",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "IRBESARTAN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120927",
"SamplePackage": "N",
"IndicationAndUsage": "Irbesartan is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2).",
"Description": "Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular formula is C25H28N6O, and the structural formula. Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: carboxymethylcellulose calcium, povidone, colloidal silicon dioxide, sodium starch glycolate, talc and magnesium stearate. The film coating comprises of hypromellose, lactose monohydrate, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "35356-047-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35356-047-30)",
"NDC11Code": "35356-0047-30",
"ProductNDC": "35356-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-12-22"
},
{
"NDCCode": "43063-047-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-047-30)",
"NDC11Code": "43063-0047-30",
"ProductNDC": "43063-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065215",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-08-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43116-047-03",
"PackageDescription": "30 U in 1 BOX (43116-047-03) ",
"NDC11Code": "43116-0047-03",
"ProductNDC": "43116-047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cleansing Wipes",
"NonProprietaryName": "Cleansing Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Shenzhen Shierjie Biological Engineering Co., LTD",
"SubstanceName": "POLIHEXANIDE HYDROCHLORIDE; BENZALKONIUM CHLORIDE",
"StrengthNumber": ".04; .05",
"StrengthUnit": "U/100U; U/100U",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251118",
"SamplePackage": "N",
"IndicationAndUsage": "Gentle cleansinng for face, neck, and body, help reduce bacteria on skin, stay hygienic."
},
{
"NDCCode": "43547-047-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-047-03) ",
"NDC11Code": "43547-0047-03",
"ProductNDC": "43547-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210609",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220118",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, ferrosoferric oxide, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, lecithin (soya), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "46708-047-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (46708-047-30) ",
"NDC11Code": "46708-0047-30",
"ProductNDC": "46708-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091367",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150106",
"SamplePackage": "N",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red."
},
{
"NDCCode": "49643-047-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-047-30) ",
"NDC11Code": "49643-0047-30",
"ProductNDC": "49643-047",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cockroach, American",
"NonProprietaryName": "Periplaneta Americana",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "PERIPLANETA AMERICANA",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
}
]
}
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<PackageDescription>30 BLISTER PACK in 1 BOX (75907-047-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-047-81) </PackageDescription>
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<ProductNDC>75907-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
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<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids.</IndicationAndUsage>
<Description>Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are oral formulations of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in cyclosporine capsules [MODIFIED] and cyclosporine oral solution, USP [MODIFIED], is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N, 4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). Each soft gelatin cyclosporine capsule, USP [Modified] for oral administration contains 25 mg or 100 mg of cyclosporine, USP. In addition, each capsule contains the following inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, gelatin, glycerin, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil, red iron oxide, shellac, sorbitol special 76% and titanium dioxide USP. Cyclosporine oral solution, USP [MODIFIED] contains 100 mg/mL of cyclosporine, USP. Inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil. The chemical structure of cyclosporine, USP (also known as cyclosporin A) is.</Description>
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<NDCCode>75907-005-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (75907-005-30) </PackageDescription>
<NDC11Code>75907-0005-30</NDC11Code>
<ProductNDC>75907-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240315</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075389</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240315</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.</IndicationAndUsage>
<Description>Amiodarone hydrochloride tablets, USP is an antiarrhythmic drug, available for oral administration as white tablets containing 100 mg of amiodarone hydrochloride, white, scored tablets containing 200 mg of amiodarone hydrochloride, and yellow, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present are lactose, starch, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, and D&C Yellow #10. Amiodarone is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]- 3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows. C25H29I2NO3 ∙ HCl Molecular Weight: 681.8. Amiodarone HCl is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>75907-007-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (75907-007-30) </PackageDescription>
<NDC11Code>75907-0007-30</NDC11Code>
<ProductNDC>75907-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amiodarone Hydrochloride</ProprietaryName>
<NonProprietaryName>Amiodarone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075389</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>AMIODARONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.</IndicationAndUsage>
<Description>Amiodarone hydrochloride tablets, USP is an antiarrhythmic drug, available for oral administration as white tablets containing 100 mg of amiodarone hydrochloride, white, scored tablets containing 200 mg of amiodarone hydrochloride, and yellow, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present are lactose, starch, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, and D&C Yellow #10. Amiodarone is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]- 3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows. C25H29I2NO3 ∙ HCl Molecular Weight: 681.8. Amiodarone HCl is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>75907-048-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81) </PackageDescription>
<NDC11Code>75907-0048-30</NDC11Code>
<ProductNDC>75907-048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065044</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids.</IndicationAndUsage>
<Description>Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are oral formulations of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in cyclosporine capsules [MODIFIED] and cyclosporine oral solution, USP [MODIFIED], is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N, 4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). Each soft gelatin cyclosporine capsule, USP [Modified] for oral administration contains 25 mg or 100 mg of cyclosporine, USP. In addition, each capsule contains the following inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, gelatin, glycerin, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil, red iron oxide, shellac, sorbitol special 76% and titanium dioxide USP. Cyclosporine oral solution, USP [MODIFIED] contains 100 mg/mL of cyclosporine, USP. Inactive ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil. The chemical structure of cyclosporine, USP (also known as cyclosporin A) is.</Description>
</NDC>
<NDC>
<NDCCode>75907-053-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-053-30) </PackageDescription>
<NDC11Code>75907-0053-30</NDC11Code>
<ProductNDC>75907-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride (la)</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078458</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>75907-059-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (75907-059-30) </PackageDescription>
<NDC11Code>75907-0059-30</NDC11Code>
<ProductNDC>75907-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamoxifen Citrate</ProprietaryName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075797</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N,N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows. C32H37NO8 M.W. 563.62. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.</Description>
</NDC>
<NDC>
<NDCCode>75907-060-30</NDCCode>
<PackageDescription>30 g in 1 BOTTLE, PLASTIC (75907-060-30) </PackageDescription>
<NDC11Code>75907-0060-30</NDC11Code>
<ProductNDC>75907-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065203</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.</Description>
</NDC>
<NDC>
<NDCCode>75907-166-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (75907-166-30) </PackageDescription>
<NDC11Code>75907-0166-30</NDC11Code>
<ProductNDC>75907-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metyrosine</ProprietaryName>
<NonProprietaryName>Metyrosine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218620</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>METYROSINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: : 1 Preoperative preparation of patients for surgery , 2 Management of patients when surgery is contraindicated , 3 Chronic treatment of patients with malignant pheochromocytoma .</IndicationAndUsage>
<Description>Metyrosine is (–)-α-methyl-L-tyrosine or (α-MPT). It has the following structural formula. Metyrosine USP is a white to off-white, crystalline compound of molecular weight 195.22. It is very slightly soluble in water, acetone, and methanol, and insoluble in chloroform and benzene. It is soluble in acidic aqueous solutions. It is also soluble in alkaline aqueous solutions but is subject to oxidative degradation under these conditions. Metyrosine is supplied as capsules for oral administration. Each capsule contains 250 mg metyrosine, USP. Inactive ingredients are colloidal silicon dioxide, FD&C Blue # 2, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains: black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>75907-169-11</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>75907-0169-11</NDC11Code>
<ProductNDC>75907-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorouracil</ProprietaryName>
<NonProprietaryName>Fluorouracil Cream, 0.5%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250706</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020985</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluorouracil cream, 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.</IndicationAndUsage>
<Description>Fluorouracil cream, 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C 4H 3FN 2O 2. Fluorouracil has a molecular weight of 130.08. Fluorouracil cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge ®) composed of methyl methacrylate/glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, glycerin, methyl gluceth-20, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine.</Description>
</NDC>
<NDC>
<NDCCode>75907-309-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (75907-309-30) </PackageDescription>
<NDC11Code>75907-0309-30</NDC11Code>
<ProductNDC>75907-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218729</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Tranexamic acid tablets, USP are an antifibrinolytic drug administered orally. The chemical name is trans-4-aminomethylcyclohexanecarboxylic acid. The structural formula is. Tranexamic acid, USP is a white crystalline powder. It is freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in Alcohol. The molecular formula is C8H15N02 and the molecular weight is 157.2. Tranexamic acid tablets, USP are provided as a white to off white, oval, biconvex tablets debossed with “A 194” on one side and plain on the other side. The active ingredient in each tablet is 650 mg tranexamic acid, USP. The inactive ingredients contained in each tablet are: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized maize starch, stearic acid and talc. FDA approved dissolution test specifications differs from USP.</Description>
</NDC>
<NDC>
<NDCCode>75907-310-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (75907-310-30) </PackageDescription>
<NDC11Code>75907-0310-30</NDC11Code>
<ProductNDC>75907-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218712</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline hydrochloride capsules contain sertraline hydrochloride, USP a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.69 and has the following chemical name: (1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white or off-white crystalline powder that is sparingly soluble or slightly soluble in absolute alcohol; slightly soluble in water and in isopropanol; and slightly or very slightly soluble in acetone. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives. The Imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>75907-311-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (75907-311-30) </PackageDescription>
<NDC11Code>75907-0311-30</NDC11Code>
<ProductNDC>75907-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218712</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride capsules is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline hydrochloride capsules contain sertraline hydrochloride, USP a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.69 and has the following chemical name: (1S,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white or off-white crystalline powder that is sparingly soluble or slightly soluble in absolute alcohol; slightly soluble in water and in isopropanol; and slightly or very slightly soluble in acetone. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives. The Imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>75907-327-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (75907-327-11) * 3 mL in 1 VIAL (75907-328-11) * 30 mL in 1 VIAL, SINGLE-DOSE (75907-326-11) </PackageDescription>
<NDC11Code>75907-0327-11</NDC11Code>
<ProductNDC>75907-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carmustine</ProprietaryName>
<NonProprietaryName>Carmustine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213207</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following. - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.</IndicationAndUsage>
<Description>The active ingredient in carmustine for injection USP, is a nitrosourea with the chemical name1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and poorly soluble in water. Carmustine for injection USP, is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine USP is. Carmustine for injection USP, is available in 100 mg single dose vials of lyophilized material.Sterile diluent for constitution of carmustine is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>75907-365-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (75907-365-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>75907-0365-30</NDC11Code>
<ProductNDC>75907-365</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone Capsules Usp, 125 Mg</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of: 1 pressure, bloating, and fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75907-405-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (75907-405-30) </PackageDescription>
<NDC11Code>75907-0405-30</NDC11Code>
<ProductNDC>75907-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosutinib</ProprietaryName>
<NonProprietaryName>Bosutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209624</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>BOSUTINIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bosutinib tablets are indicated for the treatment of: 1 Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2)]. , 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>Bosutinib tablets contains bosutinib, a kinase inhibitor. The chemical name of bosutinib is 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-hydrate (1:2). Its chemical formula is C26H29Cl2N5O3.2H2O; its molecular weight is 566.48 Bosutinib has the following chemical structure. Bosutinib is a white to yellowish-tan powder. Bosutinib is soluble in dimethyl sulfoxide, sparingly soluble in acetone and practically insoluble in water. Bosutinib tablets are supplied for oral administration in a single strength of 400 mg, equivalent to 400 mg of bosutinib on an anhydrous basis. The tablets contain the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>75907-431-30</NDCCode>
<PackageDescription>300 TABLET in 1 BOTTLE (75907-431-30) </PackageDescription>
<NDC11Code>75907-0431-30</NDC11Code>
<ProductNDC>75907-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen Diphenhydramine Hcl</ProprietaryName>
<NonProprietaryName>Acetaminophen Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75907-434-30</NDCCode>
<PackageDescription>300 TABLET in 1 BOTTLE (75907-434-30) </PackageDescription>
<NDC11Code>75907-0434-30</NDC11Code>
<ProductNDC>75907-434</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210722</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. ■ runny nose. ■ sneezing. ■ itchy, watery eyes. ■ itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10544-047-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-047-30)</PackageDescription>
<NDC11Code>10544-0047-30</NDC11Code>
<ProductNDC>10544-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040807</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine- 7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C yellow #6, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>11410-047-30</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (11410-047-30) / 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>11410-0047-30</NDC11Code>
<ProductNDC>11410-047</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactivplus Pore Clearing Treatment</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Alchemee, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the management of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11788-047-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (11788-047-03) </PackageDescription>
<NDC11Code>11788-0047-03</NDC11Code>
<ProductNDC>11788-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217579</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pale yellow powder, practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>13668-047-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-047-30) </PackageDescription>
<NDC11Code>13668-0047-30</NDC11Code>
<ProductNDC>13668-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078947</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine tablet is indicated for:. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>16590-047-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-047-30)</PackageDescription>
<NDC11Code>16590-0047-30</NDC11Code>
<ProductNDC>16590-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040622</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Promethazine hydrochloride tablets are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each tablet for oral administration contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive ingredients present are colloidal silicon dioxide, disodium EDTA, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, saccharin sodium, and sodium starch glycolate. 12.5 mg also contains - FD&C Yellow No. 5 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake; 50 mg also contains - FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>31722-047-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (31722-047-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (31722-047-01) </PackageDescription>
<NDC11Code>31722-0047-30</NDC11Code>
<ProductNDC>31722-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName>
<NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215420</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet.</IndicationAndUsage>
<Description>Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is a white to pale yellow color powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula:. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate monohydrate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>33342-047-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-047-07) </PackageDescription>
<NDC11Code>33342-0047-07</NDC11Code>
<ProductNDC>33342-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan</ProprietaryName>
<NonProprietaryName>Irbesartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202254</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>IRBESARTAN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irbesartan is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2).</IndicationAndUsage>
<Description>Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular formula is C25H28N6O, and the structural formula. Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored film-coated tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: carboxymethylcellulose calcium, povidone, colloidal silicon dioxide, sodium starch glycolate, talc and magnesium stearate. The film coating comprises of hypromellose, lactose monohydrate, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>35356-047-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35356-047-30)</PackageDescription>
<NDC11Code>35356-0047-30</NDC11Code>
<ProductNDC>35356-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120229</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>43063-047-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (43063-047-30)</PackageDescription>
<NDC11Code>43063-0047-30</NDC11Code>
<ProductNDC>43063-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065215</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43116-047-03</NDCCode>
<PackageDescription>30 U in 1 BOX (43116-047-03) </PackageDescription>
<NDC11Code>43116-0047-03</NDC11Code>
<ProductNDC>43116-047</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cleansing Wipes</ProprietaryName>
<NonProprietaryName>Cleansing Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Shenzhen Shierjie Biological Engineering Co., LTD</LabelerName>
<SubstanceName>POLIHEXANIDE HYDROCHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.04; .05</StrengthNumber>
<StrengthUnit>U/100U; U/100U</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gentle cleansinng for face, neck, and body, help reduce bacteria on skin, stay hygienic.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-047-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-047-03) </PackageDescription>
<NDC11Code>43547-0047-03</NDC11Code>
<ProductNDC>43547-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210609</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, ferrosoferric oxide, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, lecithin (soya), macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>46708-047-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (46708-047-30) </PackageDescription>
<NDC11Code>46708-0047-30</NDC11Code>
<ProductNDC>46708-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091367</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
</NDC>
<NDC>
<NDCCode>49643-047-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-047-30) </PackageDescription>
<NDC11Code>49643-0047-30</NDC11Code>
<ProductNDC>49643-047</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cockroach, American</ProprietaryName>
<NonProprietaryName>Periplaneta Americana</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>PERIPLANETA AMERICANA</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
</NDCList>