{
"NDC": [
{
"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": "75907-023-48",
"PackageDescription": "4 POUCH in 1 CARTON (75907-023-48) / 1 PATCH in 1 POUCH (75907-023-11) / 24 h in 1 PATCH",
"NDC11Code": "75907-0023-48",
"ProductNDC": "75907-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine",
"NonProprietaryName": "Clonidine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20240210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079090",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "CLONIDINE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240210",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure."
},
{
"NDCCode": "75907-024-48",
"PackageDescription": "4 POUCH in 1 CARTON (75907-024-48) / 1 PATCH in 1 POUCH (75907-024-11) / 24 h in 1 PATCH",
"NDC11Code": "75907-0024-48",
"ProductNDC": "75907-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine",
"NonProprietaryName": "Clonidine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20240210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079090",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "CLONIDINE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240210",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure."
},
{
"NDCCode": "75907-025-48",
"PackageDescription": "4 POUCH in 1 CARTON (75907-025-48) / 1 PATCH in 1 POUCH (75907-025-11) / 24 h in 1 PATCH",
"NDC11Code": "75907-0025-48",
"ProductNDC": "75907-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine",
"NonProprietaryName": "Clonidine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20240210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079090",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "CLONIDINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240210",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure."
},
{
"NDCCode": "75907-088-13",
"PackageDescription": "3 POUCH in 1 CARTON (75907-088-13) / 21 d in 1 POUCH (75907-088-11) ",
"NDC11Code": "75907-0088-13",
"ProductNDC": "75907-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloette",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "INSERT, EXTENDED RELEASE",
"RouteName": "VAGINAL",
"StartMarketingDate": "20240528",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211328",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; ETONOGESTREL",
"StrengthNumber": ".015; .12",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240528",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N"
},
{
"NDCCode": "75907-112-11",
"PackageDescription": "1 KIT in 1 CARTON (75907-112-11) * 10 mL in 1 VIAL, SINGLE-DOSE (75907-111-11) * 10 mL in 1 VIAL, SINGLE-USE (75907-110-11) ",
"NDC11Code": "75907-0112-11",
"ProductNDC": "75907-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melphalan Hydrochloride",
"NonProprietaryName": "Melphalan Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203655",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240626",
"SamplePackage": "N",
"IndicationAndUsage": "Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.",
"Description": "Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine monohydrochloride. The molecular formula is C13H18Cl2N2O2. HCl and the molecular weight is 341.67. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of∼2.5. Melphalan salt is practically insoluble in acetone and chlorinated organic solvents. Slightly soluble in methanol and ethanol. Soluble in water, 0.1 N HCl and 0.1 N NaOH. Melphalan hydrochloride for injection is supplied as a sterile,nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection toa total of 10 mL. Melphalan hydrochloride for injection is administered intravenously."
},
{
"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": "75907-225-11",
"PackageDescription": "1 VIAL in 1 CARTON (75907-225-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "75907-0225-11",
"ProductNDC": "75907-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azacitidine",
"NonProprietaryName": "Azacitidine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201537",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "AZACITIDINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"Description": "Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244.20. Azacitidine is a white to off- white powder. Azacitidine was found to be soluble in dimethyl sulphoxide, sparingly soluble in water and insoluble in acetone and ethanol. The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder."
},
{
"NDCCode": "75907-290-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (75907-290-11) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "75907-0290-11",
"ProductNDC": "75907-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Nitroprusside",
"NonProprietaryName": "Sodium Nitroprusside",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210114",
"LabelerName": "Dr.Reddy's Laboratories Inc.,",
"SubstanceName": "SODIUM NITROPRUSSIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside injection can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.",
"Description": "Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside. whose molecular formula is Na2[Fe(CN)5NO] 2H2O, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium Nitroprusside Injection is available as:. 50 mg Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection."
},
{
"NDCCode": "45963-327-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (45963-327-11)",
"NDC11Code": "45963-0327-11",
"ProductNDC": "45963-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phendimetrazine Tartrate",
"NonProprietaryName": "Phendimetrazine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040762",
"LabelerName": "Actavis, Inc.",
"SubstanceName": "PHENDIMETRAZINE TARTRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "46987-327-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46987-327-11)",
"NDC11Code": "46987-0327-11",
"ProductNDC": "46987-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Actavis Kadian LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50268-327-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-327-15) > 1 TABLET in 1 BLISTER PACK (50268-327-11) ",
"NDC11Code": "50268-0327-15",
"ProductNDC": "50268-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopirl Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205670",
"LabelerName": "AvPAK",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200812",
"SamplePackage": "N"
},
{
"NDCCode": "50419-327-11",
"PackageDescription": "10 BOTTLE in 1 CARTON (50419-327-11) / 65 mL in 1 BOTTLE (50419-327-01) ",
"NDC11Code": "50419-0327-11",
"ProductNDC": "50419-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambelvist",
"NonProprietaryName": "Gadoquatrane",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260612",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219627",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "GADOQUATRANE",
"StrengthNumber": "257.9",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260612",
"SamplePackage": "N",
"IndicationAndUsage": "AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: : 1 the central nervous system (brain, spine, and associated tissues) , 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) .",
"Description": "AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C81H128Gd4N24O32 and a molecular weight of 2,579.1 g/mol. The structural formula of gadoquatrane is. AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. The main physicochemical properties of AMBELVIST are listed in Table 2."
},
{
"NDCCode": "60687-327-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-327-01) / 1 TABLET in 1 BLISTER PACK (60687-327-11) ",
"NDC11Code": "60687-0327-01",
"ProductNDC": "60687-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201109",
"LabelerName": "American Health Packaging",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171106",
"SamplePackage": "N",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2·C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68084-327-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01) / 1 TABLET in 1 BLISTER PACK (68084-327-11) ",
"NDC11Code": "68084-0327-01",
"ProductNDC": "68084-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077091",
"LabelerName": "American Health Packaging",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090422",
"SamplePackage": "N",
"IndicationAndUsage": "Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.",
"Description": "Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake)."
},
{
"NDCCode": "68428-327-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-327-11) ",
"NDC11Code": "68428-0327-11",
"ProductNDC": "68428-327",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cobaltum Metallicum",
"NonProprietaryName": "Cobalt",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100803",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "COBALT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100803",
"SamplePackage": "N"
},
{
"NDCCode": "68462-327-11",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68462-327-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68462-0327-11",
"ProductNDC": "68462-327",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200250",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190618",
"SamplePackage": "N"
},
{
"NDCCode": "75907-044-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-044-01) ",
"NDC11Code": "75907-0044-01",
"ProductNDC": "75907-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215775",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "75907-045-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-045-01) ",
"NDC11Code": "75907-0045-01",
"ProductNDC": "75907-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215775",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "75907-046-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-046-01) ",
"NDC11Code": "75907-0046-01",
"ProductNDC": "75907-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215775",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. 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": "75907-069-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (75907-069-01) ",
"NDC11Code": "75907-0069-01",
"ProductNDC": "75907-069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-069-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (75907-069-05) ",
"NDC11Code": "75907-0069-05",
"ProductNDC": "75907-069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-070-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-01) ",
"NDC11Code": "75907-0070-01",
"ProductNDC": "75907-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-070-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-05) ",
"NDC11Code": "75907-0070-05",
"ProductNDC": "75907-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-071-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-01) ",
"NDC11Code": "75907-0071-01",
"ProductNDC": "75907-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-071-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-05) ",
"NDC11Code": "75907-0071-05",
"ProductNDC": "75907-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-072-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (75907-072-01) ",
"NDC11Code": "75907-0072-01",
"ProductNDC": "75907-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073556",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231117",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "75907-076-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (75907-076-01) ",
"NDC11Code": "75907-0076-01",
"ProductNDC": "75907-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20240901",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050536",
"LabelerName": "Dr. Reddy's Labratories Inc.",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240901",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "Erythromycin delayed-release capsules, USP capsules contain enteric-coated pellets of erythromycin base for oral administration. Each erythromycin delayed-release capsules, USP contains 250 mg of erythromycin base. Also contains: lactose NF, povidone USP, and other ingredients. The capsule shell contains gelatin NF, titanium dioxide USP, FD&C Yellow #6, D&C Yellow #10 and FD&C Red #3. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids but it is the base which is microbiologically active. Erythromycin base is (3R *, 4S *, 5S *, 6R *, 7R *, 9R *, 11R *, 12R *, 13S *, 14R *)-4-[(2,6-Dideoxy-3-C-methyl- 3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-oxacyclo-tetradecane-2,10-dione."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>75907-023-48</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (75907-023-48) / 1 PATCH in 1 POUCH (75907-023-11) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>75907-0023-48</NDC11Code>
<ProductNDC>75907-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine</ProprietaryName>
<NonProprietaryName>Clonidine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20240210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079090</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>CLONIDINE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>75907-024-48</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (75907-024-48) / 1 PATCH in 1 POUCH (75907-024-11) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>75907-0024-48</NDC11Code>
<ProductNDC>75907-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine</ProprietaryName>
<NonProprietaryName>Clonidine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20240210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079090</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>CLONIDINE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>75907-025-48</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (75907-025-48) / 1 PATCH in 1 POUCH (75907-025-11) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>75907-0025-48</NDC11Code>
<ProductNDC>75907-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine</ProprietaryName>
<NonProprietaryName>Clonidine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20240210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079090</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>CLONIDINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine transdermal system USP provides continuous systemic delivery of clonidine USP for 7 days at an approximately constant rate. Clonidine USP is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2, 6-dichloro-N-2-imidazolidinylidenebenzenamine and has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>75907-088-13</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (75907-088-13) / 21 d in 1 POUCH (75907-088-11) </PackageDescription>
<NDC11Code>75907-0088-13</NDC11Code>
<ProductNDC>75907-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloette</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>INSERT, EXTENDED RELEASE</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20240528</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211328</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; ETONOGESTREL</SubstanceName>
<StrengthNumber>.015; .12</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240528</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75907-112-11</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (75907-112-11) * 10 mL in 1 VIAL, SINGLE-DOSE (75907-111-11) * 10 mL in 1 VIAL, SINGLE-USE (75907-110-11) </PackageDescription>
<NDC11Code>75907-0112-11</NDC11Code>
<ProductNDC>75907-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melphalan Hydrochloride</ProprietaryName>
<NonProprietaryName>Melphalan Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203655</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.</IndicationAndUsage>
<Description>Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]-L-phenylalanine monohydrochloride. The molecular formula is C13H18Cl2N2O2. HCl and the molecular weight is 341.67. The structural formula is:. Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic (DL-) form is known as merphalan or sarcolysin. Melphalan is practically insoluble in water and has a pKa1 of∼2.5. Melphalan salt is practically insoluble in acetone and chlorinated organic solvents. Slightly soluble in methanol and ethanol. Soluble in water, 0.1 N HCl and 0.1 N NaOH. Melphalan hydrochloride for injection is supplied as a sterile,nonpyrogenic, freeze-dried powder. Each single-dose vial contains melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone. Melphalan hydrochloride for injection is reconstituted using the sterile diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL, ethanol (96%) 0.52 mL, and Water for Injection toa total of 10 mL. Melphalan hydrochloride for injection is administered intravenously.</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>75907-225-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (75907-225-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>75907-0225-11</NDC11Code>
<ProductNDC>75907-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azacitidine</ProprietaryName>
<NonProprietaryName>Azacitidine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201537</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>AZACITIDINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. The structural formula is as follows. The empirical formula is C8H12N4O5. The molecular weight is 244.20. Azacitidine is a white to off- white powder. Azacitidine was found to be soluble in dimethyl sulphoxide, sparingly soluble in water and insoluble in acetone and ethanol. The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.</Description>
</NDC>
<NDC>
<NDCCode>75907-290-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (75907-290-11) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>75907-0290-11</NDC11Code>
<ProductNDC>75907-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Nitroprusside</ProprietaryName>
<NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210114</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc.,</LabelerName>
<SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside injection can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.</IndicationAndUsage>
<Description>Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is. Sodium Nitroprusside. whose molecular formula is Na2[Fe(CN)5NO] 2H2O, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium Nitroprusside Injection is available as:. 50 mg Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection.</Description>
</NDC>
<NDC>
<NDCCode>45963-327-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (45963-327-11)</PackageDescription>
<NDC11Code>45963-0327-11</NDC11Code>
<ProductNDC>45963-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
<NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040762</ApplicationNumber>
<LabelerName>Actavis, Inc.</LabelerName>
<SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>46987-327-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46987-327-11)</PackageDescription>
<NDC11Code>46987-0327-11</NDC11Code>
<ProductNDC>46987-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Actavis Kadian LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50268-327-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-327-15) > 1 TABLET in 1 BLISTER PACK (50268-327-11) </PackageDescription>
<NDC11Code>50268-0327-15</NDC11Code>
<ProductNDC>50268-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopirl Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205670</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50419-327-11</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (50419-327-11) / 65 mL in 1 BOTTLE (50419-327-01) </PackageDescription>
<NDC11Code>50419-0327-11</NDC11Code>
<ProductNDC>50419-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambelvist</ProprietaryName>
<NonProprietaryName>Gadoquatrane</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260612</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219627</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GADOQUATRANE</SubstanceName>
<StrengthNumber>257.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: : 1 the central nervous system (brain, spine, and associated tissues) , 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) .</IndicationAndUsage>
<Description>AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use. The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C81H128Gd4N24O32 and a molecular weight of 2,579.1 g/mol. The structural formula of gadoquatrane is. AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection. The main physicochemical properties of AMBELVIST are listed in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>60687-327-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-327-01) / 1 TABLET in 1 BLISTER PACK (60687-327-11) </PackageDescription>
<NDC11Code>60687-0327-01</NDC11Code>
<ProductNDC>60687-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201109</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2·C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68084-327-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01) / 1 TABLET in 1 BLISTER PACK (68084-327-11) </PackageDescription>
<NDC11Code>68084-0327-01</NDC11Code>
<ProductNDC>68084-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077091</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.</IndicationAndUsage>
<Description>Glimepiride tablets USP, are an oral sulfonylurea that contains the active ingredient glimepiride USP. Chemically, glimepiride USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea (C 24H 34N 4O 5S) with a molecular weight of 490.62. Glimepiride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water. The structural formula is. Glimepiride tablets meets USP drug release test 2. Glimepiride tablets USP, contain the active ingredient glimepiride USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg tablets contain lake blend green (contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant blue FCF aluminium lake) and glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow # 10 aluminium lake and FD&C blue # 1/ brilliant blue FCF aluminium lake).</Description>
</NDC>
<NDC>
<NDCCode>68428-327-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-327-11) </PackageDescription>
<NDC11Code>68428-0327-11</NDC11Code>
<ProductNDC>68428-327</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cobaltum Metallicum</ProprietaryName>
<NonProprietaryName>Cobalt</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100803</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>COBALT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-327-11</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68462-327-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0327-11</NDC11Code>
<ProductNDC>68462-327</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200250</ApplicationNumber>
<LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75907-044-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-044-01) </PackageDescription>
<NDC11Code>75907-0044-01</NDC11Code>
<ProductNDC>75907-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride Extended-release</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215775</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>75907-045-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-045-01) </PackageDescription>
<NDC11Code>75907-0045-01</NDC11Code>
<ProductNDC>75907-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride Extended-release</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215775</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>75907-046-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-046-01) </PackageDescription>
<NDC11Code>75907-0046-01</NDC11Code>
<ProductNDC>75907-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride Extended-release</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215775</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each Diltiazem Hydrochloride Extended-Release Capsule, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem). Also contains: sucrose, povidone, hypromellose, methacrylic acid copolymer, diethyl phthalate, FD&C Red No. 40, titanium dioxide, gelatin, black ink. The 90 mg also contains FD&C Red No. 3. For oral administration. 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>75907-069-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (75907-069-01) </PackageDescription>
<NDC11Code>75907-0069-01</NDC11Code>
<ProductNDC>75907-069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-069-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (75907-069-05) </PackageDescription>
<NDC11Code>75907-0069-05</NDC11Code>
<ProductNDC>75907-069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-070-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-01) </PackageDescription>
<NDC11Code>75907-0070-01</NDC11Code>
<ProductNDC>75907-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-070-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-05) </PackageDescription>
<NDC11Code>75907-0070-05</NDC11Code>
<ProductNDC>75907-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-071-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-01) </PackageDescription>
<NDC11Code>75907-0071-01</NDC11Code>
<ProductNDC>75907-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-071-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-05) </PackageDescription>
<NDC11Code>75907-0071-05</NDC11Code>
<ProductNDC>75907-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-072-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (75907-072-01) </PackageDescription>
<NDC11Code>75907-0072-01</NDC11Code>
<ProductNDC>75907-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073556</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules, USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>75907-076-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (75907-076-01) </PackageDescription>
<NDC11Code>75907-0076-01</NDC11Code>
<ProductNDC>75907-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050536</ApplicationNumber>
<LabelerName>Dr. Reddy's Labratories Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>Erythromycin delayed-release capsules, USP capsules contain enteric-coated pellets of erythromycin base for oral administration. Each erythromycin delayed-release capsules, USP contains 250 mg of erythromycin base. Also contains: lactose NF, povidone USP, and other ingredients. The capsule shell contains gelatin NF, titanium dioxide USP, FD&C Yellow #6, D&C Yellow #10 and FD&C Red #3. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids but it is the base which is microbiologically active. Erythromycin base is (3R *, 4S *, 5S *, 6R *, 7R *, 9R *, 11R *, 12R *, 13S *, 14R *)-4-[(2,6-Dideoxy-3-C-methyl- 3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-oxacyclo-tetradecane-2,10-dione.</Description>
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