{
"NDC": [
{
"NDCCode": "71335-1800-6",
"PackageDescription": "45 TABLET in 1 BOTTLE (71335-1800-6) ",
"NDC11Code": "71335-1800-06",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "70771-1800-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (70771-1800-6) ",
"NDC11Code": "70771-1800-06",
"ProductNDC": "70771-1800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selexipag",
"NonProprietaryName": "Selexipag",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214302",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "SELEXIPAG",
"StrengthNumber": "1600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "Y",
"IndicationAndUsage": "Selexipag tablets are a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. (1.1).",
"Description": "Selexipag tablets contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N(methylsulfonyl) acetamide. It has a molecular formula of C26H32N4O4S and a molecular weight of 496.62. Selexipag has the following structural formula. Selexipag is an off white to pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. Depending on the dose strength, each round film-coated tablet for oral administration contains 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, colloidal silicon dioxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, microcrystalline cellulose and magnesium stearate. The tablets are film coated with a coating material containing hypromellose, propylene glycol, carnauba wax, titanium dioxide, along with mixtures of ferrosoferric oxide, iron oxide red or iron oxide yellow."
},
{
"NDCCode": "71335-1800-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1800-1) ",
"NDC11Code": "71335-1800-01",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "71335-1800-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-1800-2) ",
"NDC11Code": "71335-1800-02",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "71335-1800-3",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-1800-3) ",
"NDC11Code": "71335-1800-03",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "71335-1800-4",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1800-4) ",
"NDC11Code": "71335-1800-04",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "71335-1800-5",
"PackageDescription": "20 TABLET in 1 BOTTLE (71335-1800-5) ",
"NDC11Code": "71335-1800-05",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "71335-1800-7",
"PackageDescription": "120 TABLET in 1 BOTTLE (71335-1800-7) ",
"NDC11Code": "71335-1800-07",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "71335-1800-8",
"PackageDescription": "7 TABLET in 1 BOTTLE (71335-1800-8) ",
"NDC11Code": "71335-1800-08",
"ProductNDC": "71335-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 325 Mg Ec",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220224",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds."
},
{
"NDCCode": "0115-1800-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0115-1800-01) ",
"NDC11Code": "00115-1800-01",
"ProductNDC": "0115-1800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091159",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140407",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride tablets, USP contains methylphenidate hydrochloride USP, a CNS stimulant. It is available as tablets of 5 mg, 10 mg and 20 mg strengths for oral administration. Methylphenidate hydrochloride, USP is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: Lactose monohydrate, microcrystalline cellulose, stearic acid and FD&C Yellow No. 6 Aluminum Lake."
},
{
"NDCCode": "11673-200-45",
"PackageDescription": "1800 g in 1 POUCH (11673-200-45) ",
"NDC11Code": "11673-0200-45",
"ProductNDC": "11673-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Epsom Salt",
"NonProprietaryName": "Magnesium Sulfate",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Target Corporation",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190115",
"SamplePackage": "N",
"IndicationAndUsage": "External. temporarily relieves minor sprains and bruises. Internal. relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "13668-187-18",
"PackageDescription": "1800 TABLET, FILM COATED in 1 BOTTLE (13668-187-18) ",
"NDC11Code": "13668-0187-18",
"ProductNDC": "13668-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091448",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180611",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo [4,3- d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Citrate USP is formulated as blue, round, biconvex, film-coated tablets containing sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lake of indigo carmine, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "14789-122-05",
"PackageDescription": "10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07) ",
"NDC11Code": "14789-0122-05",
"ProductNDC": "14789-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorescein",
"NonProprietaryName": "Fluorescein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215709",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "FLUORESCEIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231024",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "Fluorescein Injection, is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:. MW = 376.27. Fluorescein Injection 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Fluorescein Injection 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection."
},
{
"NDCCode": "14789-123-05",
"PackageDescription": "10 VIAL in 1 CARTON (14789-123-05) / 2 mL in 1 VIAL (14789-123-07) ",
"NDC11Code": "14789-0123-05",
"ProductNDC": "14789-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorescein",
"NonProprietaryName": "Fluorescein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215709",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "FLUORESCEIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231024",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "Fluorescein Injection, is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:. MW = 376.27. Fluorescein Injection 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Fluorescein Injection 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection."
},
{
"NDCCode": "17445-6034-6",
"PackageDescription": "1500 g in 1 BOTTLE, PLASTIC (17445-6034-6) ",
"NDC11Code": "17445-6034-06",
"ProductNDC": "17445-6034",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Urea-13c",
"DosageFormName": "POWDER",
"StartMarketingDate": "19950102",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sigma-Aldrich Corporation",
"SubstanceName": "UREA C-13",
"StrengthNumber": "1800",
"StrengthUnit": "g/1800g",
"Status": "Unfinished",
"LastUpdate": "2026-06-17",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JAN-95"
},
{
"NDCCode": "17478-250-20",
"PackageDescription": "12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-250-20) > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0250-20",
"ProductNDC": "17478-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ak-fluor",
"NonProprietaryName": "Fluorescein Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022186",
"LabelerName": "Akorn",
"SubstanceName": "FLUORESCEIN SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20081001",
"SamplePackage": "N",
"IndicationAndUsage": "AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection."
},
{
"NDCCode": "17478-253-10",
"PackageDescription": "12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-253-10) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0253-10",
"ProductNDC": "17478-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ak-fluor",
"NonProprietaryName": "Fluorescein Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022186",
"LabelerName": "Akorn",
"SubstanceName": "FLUORESCEIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20081001",
"SamplePackage": "N",
"IndicationAndUsage": "AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection."
},
{
"NDCCode": "25000-131-52",
"PackageDescription": "1800 TABLET, FILM COATED in 1 BAG (25000-131-52) ",
"NDC11Code": "25000-0131-52",
"ProductNDC": "25000-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090888",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets, USP contain 500 mg, 850 mg or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide."
},
{
"NDCCode": "43353-960-42",
"PackageDescription": "1800 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-960-42) ",
"NDC11Code": "43353-0960-42",
"ProductNDC": "43353-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "50090-1800-0",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50090-1800-0) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-1800-00",
"ProductNDC": "50090-1800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate",
"NonProprietaryName": "Brimonidine Tartrate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20030528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076260",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BRIMONIDINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "Brimonidine Tartrate Ophthalmic Solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine Tartrate Ophthalmic Solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.",
"Description": "Brimonidine Tartrate Ophthalmic Solution 0.2%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent). The structural formula of brimonidine tartrate is. Chemical Name: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. CAS Number: 59803-98-4. In solution, Brimonidine Tartrate Ophthalmic Solution 0.2% has a clear, greenish-yellow color. It has an osmolality of 270 - 325 mOsml/kg and a pH range between 5.8 and 6.6. Each mL contains. ACTIVE: brimonidine tartrate: 0.2% (2 mg/mL). INACTIVES: citric acid, polyvinyl alcohol, purified water, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride (0.05 mg)."
},
{
"NDCCode": "50090-4535-0",
"PackageDescription": "5 mL in 1 VIAL, SINGLE-DOSE (50090-4535-0) ",
"NDC11Code": "50090-4535-00",
"ProductNDC": "50090-4535",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ak-fluor",
"NonProprietaryName": "Fluorescein Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022186",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "FLUORESCEIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190918",
"SamplePackage": "N",
"IndicationAndUsage": "AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection."
},
{
"NDCCode": "51316-072-45",
"PackageDescription": "1800 g in 1 POUCH (51316-072-45) ",
"NDC11Code": "51316-0072-45",
"ProductNDC": "51316-072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Epsom Salt",
"NonProprietaryName": "Magnesium Sulfate",
"DosageFormName": "GRANULE",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20220927",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS PHARMACY",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220927",
"SamplePackage": "N",
"IndicationAndUsage": "External. temporarily relieves minor sprains and bruises. Internal. relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "51662-1533-3",
"PackageDescription": "12 POUCH in 1 BOX (51662-1533-3) > 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "51662-1533-03",
"ProductNDC": "51662-1533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorescein",
"NonProprietaryName": "Fluorescein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022186",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "FLUORESCEIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Active",
"LastUpdate": "2021-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection."
},
{
"NDCCode": "53645-1800-2",
"PackageDescription": "23 g in 1 BOTTLE (53645-1800-2) ",
"NDC11Code": "53645-1800-02",
"ProductNDC": "53645-1800",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camphora",
"NonProprietaryName": "Camphora",
"DosageFormName": "GLOBULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171124",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Botanica, LLC",
"SubstanceName": "CINNAMOMUM CAMPHORA LEAF",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/23g",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171124",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of chilliness, sneezing, loss of strength. Helps with wound healing, absent mindedness.. May also be used for standard homeopathic indications or as directed by your physician."
},
{
"NDCCode": "57520-0472-1",
"PackageDescription": "1800 g in 1 JUG (57520-0472-1) ",
"NDC11Code": "57520-0472-01",
"ProductNDC": "57520-0472",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sciatic Rescue",
"NonProprietaryName": "Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens,",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111121",
"EndMarketingDate": "20230213",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apotheca Company",
"SubstanceName": "CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM",
"StrengthNumber": "6; 6; 1; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2023-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111121",
"EndMarketingDatePackage": "20230213",
"SamplePackage": "N"
},
{
"NDCCode": "57894-503-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "57894-0503-01",
"ProductNDC": "57894-503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darzalex Faspro",
"NonProprietaryName": "Daratumumab And Hyaluronidase-fihj (human Recombinant)",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761145",
"LabelerName": "Janssen Biotech, Inc.",
"SubstanceName": "DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT)",
"StrengthNumber": "1800; 30000",
"StrengthUnit": "mg/15mL; U/15mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: 1 multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant, 2 multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant, 3 multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, 4 multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, 5 multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant, 6 multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, 7 multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, 8 multiple myeloma in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, 9 multiple myeloma as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent, 10 high-risk smoldering multiple myeloma as monotherapy, 11 light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients. .",
"Description": "Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody that binds to the CD38 antigen. Daratumumab is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. The molecular weight of daratumumab is approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by Chinese Hamster Ovary cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) injection is a sterile, preservative-free, colorless to yellow, and clear to opalescent solution supplied in a single-dose vial for subcutaneous administration. Each DARZALEX FASPRO 15 mL single-dose vial contains 1,800 mg of daratumumab and 30,000 units of hyaluronidase, L-histidine (4.9 mg), L-histidine hydrochloride monohydrate (18.4 mg), L-methionine (13.5 mg), polysorbate 20 (6 mg), sorbitol (735.1 mg), and Water for Injection, USP."
},
{
"NDCCode": "62135-210-72",
"PackageDescription": "1800 TABLET in 1 BOTTLE (62135-210-72) ",
"NDC11Code": "62135-0210-72",
"ProductNDC": "62135-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090035",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220303",
"SamplePackage": "N",
"IndicationAndUsage": "Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid."
},
{
"NDCCode": "63833-891-51",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (63833-891-51) / 50 mL in 1 VIAL, SINGLE-USE (63833-891-90) ",
"NDC11Code": "63833-0891-51",
"ProductNDC": "63833-891",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Riastap",
"NonProprietaryName": "Fibrinogen Human",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090116",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125317",
"LabelerName": "CSL Behring GmbH",
"SubstanceName": "FIBRINOGEN HUMAN",
"StrengthNumber": "1300",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "RIASTAP®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.",
"Description": "RIASTAP is a sterile, heat-treated, lyophilized fibrinogen (coagulation factor I) concentrate powder manufactured from pooled human plasma. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aα, Bβ and γ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. Each RIASTAP 1 g dose vial contains 900 to 1300 mg fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Each RIASTAP 2 g dose vial contains 1800 to 2600 mg fibrinogen, 800 to 1400 mg human albumin, 750 to 1320 mg L-arginine hydrochloride, 400 to 700 mg sodium chloride and 100 to 200 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH. The pH of the reconstituted RIASTAP is in a range of 6.5 to 7.5."
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{
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"PackageDescription": "1 VIAL, GLASS in 1 CARTON (63833-892-51) / 100 mL in 1 VIAL, GLASS (63833-892-90) ",
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"ProductNDC": "63833-892",
"ProductTypeName": "PLASMA DERIVATIVE",
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"NonProprietaryName": "Fibrinogen Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20090116",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125317",
"LabelerName": "CSL Behring GmbH",
"SubstanceName": "FIBRINOGEN HUMAN",
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"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "RIASTAP®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.",
"Description": "RIASTAP is a sterile, heat-treated, lyophilized fibrinogen (coagulation factor I) concentrate powder manufactured from pooled human plasma. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aα, Bβ and γ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. Each RIASTAP 1 g dose vial contains 900 to 1300 mg fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Each RIASTAP 2 g dose vial contains 1800 to 2600 mg fibrinogen, 800 to 1400 mg human albumin, 750 to 1320 mg L-arginine hydrochloride, 400 to 700 mg sodium chloride and 100 to 200 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH. The pH of the reconstituted RIASTAP is in a range of 6.5 to 7.5."
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{
"NDCCode": "66215-718-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "66215-0718-01",
"ProductNDC": "66215-718",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uptravi",
"NonProprietaryName": "Selexipag",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214275",
"LabelerName": "Actelion Pharmaceuticals US, Inc.",
"SubstanceName": "SELEXIPAG",
"StrengthNumber": "1800",
"StrengthUnit": "ug/10mL",
"Pharm_Classes": "Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210729",
"SamplePackage": "N",
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"Description": "UPTRAVI contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide. It has a molecular formula of C26H32N4O4S and a molecular weight of 496.62. Selexipag has the following structural formula. Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. UPTRAVI® (selexipag) tablets: depending on the dose strength, each round film-coated tablet for oral administration contains 100, 150, 200, 400, 600, 800, 1,000, 1,200, 1,400, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, D-mannitol, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, and magnesium stearate. The tablets are film coated with a coating material containing carnauba wax, hypromellose, propylene glycol, titanium dioxide, along with mixtures of iron oxide black, iron oxide red and/or iron oxide yellow. The coating material of the 100 mcg and 150 mcg tablets also contains talc. UPTRAVI® (selexipag) for injection: contains 1,800 mcg of selexipag per vial. UPTRAVI for injection includes the following inactive ingredients: glycine (180 mg), phosphoric acid (3.53 mg), polysorbate 20 (10.8 mg) and sodium hydroxide (for pH adjustment). UPTRAVI for injection is provided in 10 mL Type I clear glass vials closed by a stopper and tear-off aluminum seal."
}
]
}
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<PackageDescription>30 TABLET in 1 BOTTLE (71335-1800-1) </PackageDescription>
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<ProductNDC>71335-1800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>60 TABLET in 1 BOTTLE (71335-1800-2) </PackageDescription>
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<ProductNDC>71335-1800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 325 Mg Ec</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<SubstanceName>ASPIRIN</SubstanceName>
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<PackageDescription>100 TABLET in 1 BOTTLE (71335-1800-3) </PackageDescription>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>90 TABLET in 1 BOTTLE (71335-1800-4) </PackageDescription>
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<ProductNDC>71335-1800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 325 Mg Ec</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
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<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
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<LastUpdate>2025-04-03</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
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<ProductNDC>71335-1800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 325 Mg Ec</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
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<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
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<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>7 TABLET in 1 BOTTLE (71335-1800-8) </PackageDescription>
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<ProductNDC>71335-1800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 325 Mg Ec</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves. : 1 headache, 2 menstrual pain, 3 minor pain of arthritis, 4 muscle pain, 5 toothache, 6 pain and fever of colds.</IndicationAndUsage>
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<NDC>
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<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0115-1800-01) </PackageDescription>
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<ProductNDC>0115-1800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091159</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride tablets are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride tablets, USP contains methylphenidate hydrochloride USP, a CNS stimulant. It is available as tablets of 5 mg, 10 mg and 20 mg strengths for oral administration. Methylphenidate hydrochloride, USP is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride, USP is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: Lactose monohydrate, microcrystalline cellulose, stearic acid and FD&C Yellow No. 6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>11673-200-45</NDCCode>
<PackageDescription>1800 g in 1 POUCH (11673-200-45) </PackageDescription>
<NDC11Code>11673-0200-45</NDC11Code>
<ProductNDC>11673-200</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Epsom Salt</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
<DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>External. temporarily relieves minor sprains and bruises. Internal. relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-187-18</NDCCode>
<PackageDescription>1800 TABLET, FILM COATED in 1 BOTTLE (13668-187-18) </PackageDescription>
<NDC11Code>13668-0187-18</NDC11Code>
<ProductNDC>13668-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091448</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo [4,3- d] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Citrate USP is formulated as blue, round, biconvex, film-coated tablets containing sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lake of indigo carmine, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>14789-122-05</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07) </PackageDescription>
<NDC11Code>14789-0122-05</NDC11Code>
<ProductNDC>14789-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorescein</ProprietaryName>
<NonProprietaryName>Fluorescein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215709</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUORESCEIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>Fluorescein Injection, is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:. MW = 376.27. Fluorescein Injection 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Fluorescein Injection 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>14789-123-05</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (14789-123-05) / 2 mL in 1 VIAL (14789-123-07) </PackageDescription>
<NDC11Code>14789-0123-05</NDC11Code>
<ProductNDC>14789-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorescein</ProprietaryName>
<NonProprietaryName>Fluorescein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215709</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUORESCEIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>Fluorescein Injection, is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:. MW = 376.27. Fluorescein Injection 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Fluorescein Injection 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>17445-6034-6</NDCCode>
<PackageDescription>1500 g in 1 BOTTLE, PLASTIC (17445-6034-6) </PackageDescription>
<NDC11Code>17445-6034-06</NDC11Code>
<ProductNDC>17445-6034</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Urea-13c</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19950102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sigma-Aldrich Corporation</LabelerName>
<SubstanceName>UREA C-13</SubstanceName>
<StrengthNumber>1800</StrengthNumber>
<StrengthUnit>g/1800g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-06-17</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-95</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>17478-250-20</NDCCode>
<PackageDescription>12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-250-20) > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0250-20</NDC11Code>
<ProductNDC>17478-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ak-fluor</ProprietaryName>
<NonProprietaryName>Fluorescein Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022186</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>17478-253-10</NDCCode>
<PackageDescription>12 VIAL, SINGLE-DOSE in 1 PACKAGE (17478-253-10) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0253-10</NDC11Code>
<ProductNDC>17478-253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ak-fluor</ProprietaryName>
<NonProprietaryName>Fluorescein Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022186</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>25000-131-52</NDCCode>
<PackageDescription>1800 TABLET, FILM COATED in 1 BAG (25000-131-52) </PackageDescription>
<NDC11Code>25000-0131-52</NDC11Code>
<ProductNDC>25000-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090888</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets, USP contain 500 mg, 850 mg or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-960-42</NDCCode>
<PackageDescription>1800 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-960-42) </PackageDescription>
<NDC11Code>43353-0960-42</NDC11Code>
<ProductNDC>43353-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1800-0</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50090-1800-0) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50090-1800-00</NDC11Code>
<ProductNDC>50090-1800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20030528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076260</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brimonidine Tartrate Ophthalmic Solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine Tartrate Ophthalmic Solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.</IndicationAndUsage>
<Description>Brimonidine Tartrate Ophthalmic Solution 0.2%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent). The structural formula of brimonidine tartrate is. Chemical Name: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. CAS Number: 59803-98-4. In solution, Brimonidine Tartrate Ophthalmic Solution 0.2% has a clear, greenish-yellow color. It has an osmolality of 270 - 325 mOsml/kg and a pH range between 5.8 and 6.6. Each mL contains. ACTIVE: brimonidine tartrate: 0.2% (2 mg/mL). INACTIVES: citric acid, polyvinyl alcohol, purified water, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride (0.05 mg).</Description>
</NDC>
<NDC>
<NDCCode>50090-4535-0</NDCCode>
<PackageDescription>5 mL in 1 VIAL, SINGLE-DOSE (50090-4535-0) </PackageDescription>
<NDC11Code>50090-4535-00</NDC11Code>
<ProductNDC>50090-4535</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ak-fluor</ProprietaryName>
<NonProprietaryName>Fluorescein Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022186</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains:. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains:. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>51316-072-45</NDCCode>
<PackageDescription>1800 g in 1 POUCH (51316-072-45) </PackageDescription>
<NDC11Code>51316-0072-45</NDC11Code>
<ProductNDC>51316-072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Epsom Salt</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20220927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CVS PHARMACY</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>External. temporarily relieves minor sprains and bruises. Internal. relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51662-1533-3</NDCCode>
<PackageDescription>12 POUCH in 1 BOX (51662-1533-3) > 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>51662-1533-03</NDC11Code>
<ProductNDC>51662-1533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorescein</ProprietaryName>
<NonProprietaryName>Fluorescein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022186</ApplicationNumber>
<LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure. MW = 376.27. AK-FLUOR® 10% contains. Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR® 25% contains. Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL). Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>53645-1800-2</NDCCode>
<PackageDescription>23 g in 1 BOTTLE (53645-1800-2) </PackageDescription>
<NDC11Code>53645-1800-02</NDC11Code>
<ProductNDC>53645-1800</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camphora</ProprietaryName>
<NonProprietaryName>Camphora</NonProprietaryName>
<DosageFormName>GLOBULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Botanica, LLC</LabelerName>
<SubstanceName>CINNAMOMUM CAMPHORA LEAF</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/23g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of chilliness, sneezing, loss of strength. Helps with wound healing, absent mindedness.. May also be used for standard homeopathic indications or as directed by your physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57520-0472-1</NDCCode>
<PackageDescription>1800 g in 1 JUG (57520-0472-1) </PackageDescription>
<NDC11Code>57520-0472-01</NDC11Code>
<ProductNDC>57520-0472</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sciatic Rescue</ProprietaryName>
<NonProprietaryName>Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens,</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111121</StartMarketingDate>
<EndMarketingDate>20230213</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apotheca Company</LabelerName>
<SubstanceName>CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM</SubstanceName>
<StrengthNumber>6; 6; 1; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111121</StartMarketingDatePackage>
<EndMarketingDatePackage>20230213</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57894-503-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>57894-0503-01</NDC11Code>
<ProductNDC>57894-503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darzalex Faspro</ProprietaryName>
<NonProprietaryName>Daratumumab And Hyaluronidase-fihj (human Recombinant)</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761145</ApplicationNumber>
<LabelerName>Janssen Biotech, Inc.</LabelerName>
<SubstanceName>DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT)</SubstanceName>
<StrengthNumber>1800; 30000</StrengthNumber>
<StrengthUnit>mg/15mL; U/15mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: 1 multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant, 2 multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant, 3 multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, 4 multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, 5 multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant, 6 multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, 7 multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, 8 multiple myeloma in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, 9 multiple myeloma as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent, 10 high-risk smoldering multiple myeloma as monotherapy, 11 light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients. .</IndicationAndUsage>
<Description>Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody that binds to the CD38 antigen. Daratumumab is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. The molecular weight of daratumumab is approximately 148 kDa. Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by Chinese Hamster Ovary cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) injection is a sterile, preservative-free, colorless to yellow, and clear to opalescent solution supplied in a single-dose vial for subcutaneous administration. Each DARZALEX FASPRO 15 mL single-dose vial contains 1,800 mg of daratumumab and 30,000 units of hyaluronidase, L-histidine (4.9 mg), L-histidine hydrochloride monohydrate (18.4 mg), L-methionine (13.5 mg), polysorbate 20 (6 mg), sorbitol (735.1 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>62135-210-72</NDCCode>
<PackageDescription>1800 TABLET in 1 BOTTLE (62135-210-72) </PackageDescription>
<NDC11Code>62135-0210-72</NDC11Code>
<ProductNDC>62135-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090035</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>63833-891-51</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (63833-891-51) / 50 mL in 1 VIAL, SINGLE-USE (63833-891-90) </PackageDescription>
<NDC11Code>63833-0891-51</NDC11Code>
<ProductNDC>63833-891</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Riastap</ProprietaryName>
<NonProprietaryName>Fibrinogen Human</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090116</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125317</ApplicationNumber>
<LabelerName>CSL Behring GmbH</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN</SubstanceName>
<StrengthNumber>1300</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RIASTAP®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.</IndicationAndUsage>
<Description>RIASTAP is a sterile, heat-treated, lyophilized fibrinogen (coagulation factor I) concentrate powder manufactured from pooled human plasma. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aα, Bβ and γ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. Each RIASTAP 1 g dose vial contains 900 to 1300 mg fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Each RIASTAP 2 g dose vial contains 1800 to 2600 mg fibrinogen, 800 to 1400 mg human albumin, 750 to 1320 mg L-arginine hydrochloride, 400 to 700 mg sodium chloride and 100 to 200 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH. The pH of the reconstituted RIASTAP is in a range of 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>63833-892-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (63833-892-51) / 100 mL in 1 VIAL, GLASS (63833-892-90) </PackageDescription>
<NDC11Code>63833-0892-51</NDC11Code>
<ProductNDC>63833-892</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Riastap</ProprietaryName>
<NonProprietaryName>Fibrinogen Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20090116</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125317</ApplicationNumber>
<LabelerName>CSL Behring GmbH</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN</SubstanceName>
<StrengthNumber>2600</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RIASTAP®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.</IndicationAndUsage>
<Description>RIASTAP is a sterile, heat-treated, lyophilized fibrinogen (coagulation factor I) concentrate powder manufactured from pooled human plasma. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aα, Bβ and γ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. Each RIASTAP 1 g dose vial contains 900 to 1300 mg fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Each RIASTAP 2 g dose vial contains 1800 to 2600 mg fibrinogen, 800 to 1400 mg human albumin, 750 to 1320 mg L-arginine hydrochloride, 400 to 700 mg sodium chloride and 100 to 200 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH. The pH of the reconstituted RIASTAP is in a range of 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>66215-718-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>66215-0718-01</NDC11Code>
<ProductNDC>66215-718</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uptravi</ProprietaryName>
<NonProprietaryName>Selexipag</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214275</ApplicationNumber>
<LabelerName>Actelion Pharmaceuticals US, Inc.</LabelerName>
<SubstanceName>SELEXIPAG</SubstanceName>
<StrengthNumber>1800</StrengthNumber>
<StrengthUnit>ug/10mL</StrengthUnit>
<Pharm_Classes>Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): 1 In adults to delay disease progression and reduce the risk of hospitalization for PAH. (1.1), 2 In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. (1.1).</IndicationAndUsage>
<Description>UPTRAVI contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide. It has a molecular formula of C26H32N4O4S and a molecular weight of 496.62. Selexipag has the following structural formula. Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. UPTRAVI® (selexipag) tablets: depending on the dose strength, each round film-coated tablet for oral administration contains 100, 150, 200, 400, 600, 800, 1,000, 1,200, 1,400, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, D-mannitol, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, and magnesium stearate. The tablets are film coated with a coating material containing carnauba wax, hypromellose, propylene glycol, titanium dioxide, along with mixtures of iron oxide black, iron oxide red and/or iron oxide yellow. The coating material of the 100 mcg and 150 mcg tablets also contains talc. UPTRAVI® (selexipag) for injection: contains 1,800 mcg of selexipag per vial. UPTRAVI for injection includes the following inactive ingredients: glycine (180 mg), phosphoric acid (3.53 mg), polysorbate 20 (10.8 mg) and sodium hydroxide (for pH adjustment). UPTRAVI for injection is provided in 10 mL Type I clear glass vials closed by a stopper and tear-off aluminum seal.</Description>
</NDC>
</NDCList>