{
"NDC": [
{
"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": "75907-005-30",
"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": "75907-047-30",
"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": "75907-048-30",
"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": "20271231",
"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": "20271231",
"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": "20271231",
"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",
"IndicationAndUsage": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
},
{
"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": "10056-007-01",
"PackageDescription": "30 mL in 1 BOTTLE (10056-007-01) ",
"NDC11Code": "10056-0007-01",
"ProductNDC": "10056-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Essential By Artistry Anti Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170329",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N"
},
{
"NDCCode": "10544-007-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-007-30)",
"NDC11Code": "10544-0007-30",
"ProductNDC": "10544-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100720",
"EndMarketingDate": "20190228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "10702-007-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (10702-007-03) ",
"NDC11Code": "10702-0007-03",
"ProductNDC": "10702-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078048",
"LabelerName": "KVK-TECH, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140731",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose."
},
{
"NDCCode": "12064-007-00",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (12064-007-00)",
"NDC11Code": "12064-0007-00",
"ProductNDC": "12064-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soriatane",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100104",
"MarketingCategoryName": "APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"ApplicationNumber": "NDA019821",
"LabelerName": "GlaxoSmithKline Manufacturing SpA",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "17.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13107-007-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13107-007-30)",
"NDC11Code": "13107-0007-30",
"ProductNDC": "13107-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.",
"Description": "Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol."
},
{
"NDCCode": "13107-007-32",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (13107-007-32)",
"NDC11Code": "13107-0007-32",
"ProductNDC": "13107-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.",
"Description": "Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol."
},
{
"NDCCode": "13668-007-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-007-30) ",
"NDC11Code": "13668-0007-30",
"ProductNDC": "13668-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.",
"Description": "Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
},
{
"NDCCode": "14783-007-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-007-02) > 30 g in 1 TUBE (14783-007-01)",
"NDC11Code": "14783-0007-02",
"ProductNDC": "14783-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "Obscure 8 - Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16555-007-01",
"PackageDescription": "1 TUBE in 1 CARTON (16555-007-01) > 30 mL in 1 TUBE",
"NDC11Code": "16555-0007-01",
"ProductNDC": "16555-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Darphin Cc Instant Multi-benefit Care Broad Spectrum Spf 35",
"NonProprietaryName": "Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "DARPHIN DIST.",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".08175; .0436; .02725; .01199",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20141001",
"SamplePackage": "N"
},
{
"NDCCode": "16729-007-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-007-10) ",
"NDC11Code": "16729-0007-10",
"ProductNDC": "16729-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080226",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
},
{
"NDCCode": "21695-007-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-007-30)",
"NDC11Code": "21695-0007-30",
"ProductNDC": "21695-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Use for temporary relief of minor aches and pains due to. ° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever."
},
{
"NDCCode": "24236-007-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (24236-007-02)",
"NDC11Code": "24236-0007-02",
"ProductNDC": "24236-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-07-27"
},
{
"NDCCode": "27281-007-96",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-007-96)",
"NDC11Code": "27281-0007-96",
"ProductNDC": "27281-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diabetigen",
"NonProprietaryName": "Arnica Montana, Arsenic Trioxide, Herring Sperm Nda, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, And Uranyl Nitrate Hexahydrate",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131209",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "ARNICA MONTANA; ARSENIC TRIOXIDE; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE",
"StrengthNumber": "1.5; 200; 3; 1.5; 1.5; 1.5; 3; 3; 3; 200; 1.5; 30; 1.5; 30",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporarily relieves symptoms associated with type II diabetes, including: pancreatic deficiency; liver weakness; apathy and generalized feelings of weakness."
}
]
}
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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>75907-005-30</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>
</NDC>
<NDC>
<NDCCode>75907-047-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX (75907-047-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-047-81) </PackageDescription>
<NDC11Code>75907-0047-30</NDC11Code>
<ProductNDC>75907-047</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>25</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>75907-048-30</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>20271231</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>20271231</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>20271231</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>
<IndicationAndUsage>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</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>10056-007-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (10056-007-01) </PackageDescription>
<NDC11Code>10056-0007-01</NDC11Code>
<ProductNDC>10056-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Essential By Artistry Anti Acne Treatment</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170329</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Access Business Group LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10544-007-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (10544-007-30)</PackageDescription>
<NDC11Code>10544-0007-30</NDC11Code>
<ProductNDC>10544-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100720</StartMarketingDate>
<EndMarketingDate>20190228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>10702-007-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (10702-007-03) </PackageDescription>
<NDC11Code>10702-0007-03</NDC11Code>
<ProductNDC>10702-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078048</ApplicationNumber>
<LabelerName>KVK-TECH, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>12064-007-00</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (12064-007-00)</PackageDescription>
<NDC11Code>12064-0007-00</NDC11Code>
<ProductNDC>12064-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soriatane</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100104</StartMarketingDate>
<MarketingCategoryName>APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<ApplicationNumber>NDA019821</ApplicationNumber>
<LabelerName>GlaxoSmithKline Manufacturing SpA</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>17.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13107-007-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13107-007-30)</PackageDescription>
<NDC11Code>13107-0007-30</NDC11Code>
<ProductNDC>13107-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.</IndicationAndUsage>
<Description>Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>13107-007-32</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (13107-007-32)</PackageDescription>
<NDC11Code>13107-0007-32</NDC11Code>
<ProductNDC>13107-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.</IndicationAndUsage>
<Description>Citalopram hydrobromide USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>13668-007-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-007-30) </PackageDescription>
<NDC11Code>13668-0007-30</NDC11Code>
<ProductNDC>13668-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
<Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>14783-007-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-007-02) > 30 g in 1 TUBE (14783-007-01)</PackageDescription>
<NDC11Code>14783-0007-02</NDC11Code>
<ProductNDC>14783-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>Obscure 8 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16555-007-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16555-007-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>16555-0007-01</NDC11Code>
<ProductNDC>16555-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Darphin Cc Instant Multi-benefit Care Broad Spectrum Spf 35</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>DARPHIN DIST.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.08175; .0436; .02725; .01199</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16729-007-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-007-10) </PackageDescription>
<NDC11Code>16729-0007-10</NDC11Code>
<ProductNDC>16729-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>21695-007-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-007-30)</PackageDescription>
<NDC11Code>21695-0007-30</NDC11Code>
<ProductNDC>21695-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use for temporary relief of minor aches and pains due to. ° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24236-007-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (24236-007-02)</PackageDescription>
<NDC11Code>24236-0007-02</NDC11Code>
<ProductNDC>24236-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040218</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>27281-007-96</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-007-96)</PackageDescription>
<NDC11Code>27281-0007-96</NDC11Code>
<ProductNDC>27281-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diabetigen</ProprietaryName>
<NonProprietaryName>Arnica Montana, Arsenic Trioxide, Herring Sperm Nda, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, And Uranyl Nitrate Hexahydrate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131209</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>ARNICA MONTANA; ARSENIC TRIOXIDE; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>1.5; 200; 3; 1.5; 1.5; 1.5; 3; 3; 3; 200; 1.5; 30; 1.5; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporarily relieves symptoms associated with type II diabetes, including: pancreatic deficiency; liver weakness; apathy and generalized feelings of weakness.</IndicationAndUsage>
</NDC>
</NDCList>