{
"NDC": [
{
"NDCCode": "81279-117-88",
"PackageDescription": "60 TABLET in 1 BOTTLE (81279-117-88) ",
"NDC11Code": "81279-0117-88",
"ProductNDC": "81279-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088149",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.",
"Description": "Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. Each tablet, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6."
},
{
"NDCCode": "81279-117-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (81279-117-60) ",
"NDC11Code": "81279-0117-60",
"ProductNDC": "81279-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088149",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.",
"Description": "Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. DEXLYT TM, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6."
},
{
"NDCCode": "57664-117-88",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57664-117-88) ",
"NDC11Code": "57664-0117-88",
"ProductNDC": "57664-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120101",
"EndMarketingDate": "20201130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090529",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120101",
"EndMarketingDatePackage": "20201130",
"SamplePackage": "N"
},
{
"NDCCode": "72344-117-03",
"PackageDescription": "88 mL in 1 TUBE (72344-117-03) ",
"NDC11Code": "72344-0117-03",
"ProductNDC": "72344-117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Surface Sun Spf 50 Dry Touch Fragrance Free",
"NonProprietaryName": "Homosalate 10.00% Octocrylene 6.00% Avobenzone 3.00%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260505",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Surface Products Corp",
"SubstanceName": "HOMOSALATE; OCTOCRYLENE; AVOBENZONE",
"StrengthNumber": "10; 6; 3",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260505",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn higher SPF gives more sun protection."
},
{
"NDCCode": "72476-117-21",
"PackageDescription": "88 mL in 1 TUBE (72476-117-21) ",
"NDC11Code": "72476-0117-21",
"ProductNDC": "72476-117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalat, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211130",
"EndMarketingDate": "20260217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Retail Business Services, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 100",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211130",
"EndMarketingDatePackage": "20260217",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "73102-117-03",
"PackageDescription": "88 mL in 1 TUBE (73102-117-03) ",
"NDC11Code": "73102-0117-03",
"ProductNDC": "73102-117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minted Leaf Heat Therapy Relief Roll-on",
"NonProprietaryName": "Capsaicin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "MMG Consumer Brands, LLC",
"SubstanceName": "CAPSAICIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis. simple backache. sprains. bruises and strains."
},
{
"NDCCode": "76209-117-03",
"PackageDescription": "88.7 mL in 1 BOTTLE, SPRAY (76209-117-03) ",
"NDC11Code": "76209-0117-03",
"ProductNDC": "76209-117",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Market America Antibacterial Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210311",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Market America, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210311",
"SamplePackage": "N",
"IndicationAndUsage": " For hand sanitizing to decrease bacteria on the skin."
},
{
"NDCCode": "81279-100-50",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (81279-100-50) / 50 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "81279-0100-50",
"ProductNDC": "81279-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops",
"NonProprietaryName": "Vitamin A (as Retinyl Palmitate) Vitamin C (as Ascorbic Acid) Vitamin D3 (as Cholecalciferol) Vitamin E (as D-alpha-tocopherol Acetate) Vitamin B1 (as Thiamine Hcl) Vitamin B2 (as Riboflavin Phosphate Sodium) Niacin (as Niacinamide) Vitamin B6 (pyridoxine Hcl) Folate (as 69 Mcg Quatrefolic ((6s)-5 Methyltetrahydrofolate, Glucosamine Salt, Molar Equivalent To 37.5 Mcg Of Folic Acid)) Vitamin B12 (as Cyanocobalamin) Fluoride (as Sodium Fluoride)",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20231220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE",
"StrengthNumber": "3.35; 36; 10; 2; 117; 4; .4; .6; .25; .5; 450",
"StrengthUnit": "mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231220",
"SamplePackage": "N",
"IndicationAndUsage": "Florafol Pediatric 0.25 mg/mL Fluoride, is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride."
},
{
"NDCCode": "81279-101-50",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (81279-101-50) / 50 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "81279-0101-50",
"ProductNDC": "81279-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Florafol Fe Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops",
"NonProprietaryName": "Vitamin A (as Retinyl Palmitate) Vitamin C (as Ascorbic Acid) Vitamin D3 (as Cholecalciferol) Vitamin E (as D-alpha-tocopherol Acetate) Vitamin B1 (as Thiamine Hcl) Vitamin B2 (as Riboflavin Phosphate Sodium) Niacin (as Niacinamide) Vitamin B6 (pyridoxine Hcl) Folate (as 69 Mcg Quatrefolic ((6s)-5 Methyltetrahydrofolate, Glucosamine Salt, Molar Equivalent To 37.5 Mcg Of Folic Acid)) Vitamin B12 (as Cyanocobalamin) Iron (as Ferrous Sulfate) Fluoride (as Sodium Fluoride)",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20231220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS SULFATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE",
"StrengthNumber": "3.35; 36; 10; 2; 9.5; 117; 4; .4; .6; .25; .5; 450",
"StrengthUnit": "mg/mL; mg/mL; ug/mL; ug/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231220",
"SamplePackage": "N",
"IndicationAndUsage": "Florafol FE Pediatric 0.25 mg/mL Fluoride (with Iron), is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride."
},
{
"NDCCode": "81279-133-10",
"PackageDescription": "10 BOTTLE in 1 CARTON (81279-133-10) / 2.5 mg in 1 BOTTLE",
"NDC11Code": "81279-0133-10",
"ProductNDC": "81279-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sdamlo",
"NonProprietaryName": "Amlodipine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219531",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/2.5mg",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"Description": "Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Sdamlo is supplied as a white to off-white powder or powder cake packaged in a unit-dose, single-use container. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively, and the following inactive ingredients: mannitol and neotame. Sdamlo is for oral administration after reconstitution with water [see Dosage and Administration (2.3)] ."
},
{
"NDCCode": "81279-134-10",
"PackageDescription": "10 BOTTLE in 1 CARTON (81279-134-10) / 5 mg in 1 BOTTLE",
"NDC11Code": "81279-0134-10",
"ProductNDC": "81279-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sdamlo",
"NonProprietaryName": "Amlodipine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219531",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mg",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"Description": "Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Sdamlo is supplied as a white to off-white powder or powder cake packaged in a unit-dose, single-use container. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively, and the following inactive ingredients: mannitol and neotame. Sdamlo is for oral administration after reconstitution with water [see Dosage and Administration (2.3)] ."
},
{
"NDCCode": "81279-135-10",
"PackageDescription": "10 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLE",
"NDC11Code": "81279-0135-10",
"ProductNDC": "81279-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sdamlo",
"NonProprietaryName": "Amlodipine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219531",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mg",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"Description": "Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Sdamlo is supplied as a white to off-white powder or powder cake packaged in a unit-dose, single-use container. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively, and the following inactive ingredients: mannitol and neotame. Sdamlo is for oral administration after reconstitution with water [see Dosage and Administration (2.3)] ."
},
{
"NDCCode": "54348-117-00",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-00) > 1 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-00",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-02",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-02) > 2 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-02",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-03",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-03) > 3 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-03",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-04",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-04) > 4 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-04",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-05",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-05) > 5 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-05",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-06",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-06) > 6 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-06",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-08",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-08) > 8 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-08",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-09",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-09) > 9 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-09",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-10",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-10) > 10 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-10",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "54348-117-12",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-117-12) > 12 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0117-12",
"ProductNDC": "54348-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine",
"NonProprietaryName": "Promethazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040712",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2022-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190711",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "66689-694-88",
"PackageDescription": "4000 mL in 1 BOTTLE (66689-694-88) ",
"NDC11Code": "66689-0694-88",
"ProductNDC": "66689-694",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20091030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040088",
"LabelerName": "VistaPharm, LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240819",
"SamplePackage": "N",
"IndicationAndUsage": "Methadone hydrochloride oral concentrate contains methadone, an opioid agonist indicated for the: : 1 detoxification treatment of opioid addiction (heroin or other morphine-like drugs). , 2 maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .",
"Description": "Methadone hydrochloride oral concentrate, USP contains methadone, an opioid agonist, and is available as a cherry-flavored liquid concentrate for oral administration. Methadone hydrochloride oral concentrate, USP sugar-free is a dye-free, sugar-free, unflavored liquid concentrate of methadone hydrochloride for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptone hydrochloride. Methadone hydrochloride, USP is a fine white powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in methadone hydrochloride oral concentrate as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and a molecular weight of 345.91. Its structural formula is C21H27NOHCl. Each liquid concentrate contains 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone) per mL and the following inactive ingredients: artificial cherry flavor, sorbic acid, potassium sorbate, FD&C Red No. 40, D&C Red No. 33, poloxamer 188, propylene glycol, glycerin, sucrose, and purified water. Other ingredients of methadone hydrochloride oral concentrate, USP (dye-free, sugar-free, unflavored): citric acid anhydrous, purified water, sodium benzoate."
},
{
"NDCCode": "81279-102-30",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (81279-102-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "81279-0102-30",
"ProductNDC": "81279-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Florafol",
"NonProprietaryName": "Multivitamin And Fluoride Supplement",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE",
"StrengthNumber": "11.5; 70; 12; 3.5; 250; 12; 1.15; 1; .5; 1; 700",
"StrengthUnit": "mg/1; mg/1; ng/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N"
},
{
"NDCCode": "81279-103-30",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (81279-103-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "81279-0103-30",
"ProductNDC": "81279-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Florafol",
"NonProprietaryName": "Multivitamin And Fluoride Supplement",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE",
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"StrengthUnit": "mg/1; mg/1; ng/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
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"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240801",
"SamplePackage": "N"
},
{
"NDCCode": "81279-104-03",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (81279-104-03) / 3 TABLET in 1 BLISTER PACK",
"NDC11Code": "81279-0104-03",
"ProductNDC": "81279-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ergomar",
"ProprietaryNameSuffix": "Sublingual",
"NonProprietaryName": "Ergotamine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087693",
"LabelerName": "Pangea Pharmaceuticals LLC",
"SubstanceName": "ERGOTAMINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Active",
"LastUpdate": "2025-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250203",
"SamplePackage": "N",
"IndicationAndUsage": "Ergomar ®is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called \"histaminic cephalalgia\".",
"Description": "Ergomar ®Sublingual Tablets. Ergotamine Tartrate Sublingual Tablets USP ... 2 mg. Inactive Ingredients:Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "81279-104-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (81279-104-20) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "81279-0104-20",
"ProductNDC": "81279-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ergomar",
"ProprietaryNameSuffix": "Sublingual",
"NonProprietaryName": "Ergotamine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087693",
"LabelerName": "Pangea Pharmaceuticals LLC",
"SubstanceName": "ERGOTAMINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Active",
"LastUpdate": "2025-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250203",
"SamplePackage": "N",
"IndicationAndUsage": "Ergomar ®is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called \"histaminic cephalalgia\".",
"Description": "Ergomar ®Sublingual Tablets. Ergotamine Tartrate Sublingual Tablets USP ... 2 mg. Inactive Ingredients:Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "81279-106-05",
"PackageDescription": "5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (81279-106-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (81279-106-01) ",
"NDC11Code": "81279-0106-05",
"ProductNDC": "81279-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selenious Acid",
"NonProprietaryName": "Selenious Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Pangea Pharmaceuticals, LLC",
"SubstanceName": "SELENIUM",
"StrengthNumber": "40",
"StrengthUnit": "ug/mL",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Selenium Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.",
"Description": "Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental selenium 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4."
},
{
"NDCCode": "81279-121-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (81279-121-30) ",
"NDC11Code": "81279-0121-30",
"ProductNDC": "81279-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bucapsol",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218628",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "BUSPIRONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"IndicationAndUsage": "Bucapsol TMcapsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Bucapsol TMcapsules are antianxiety agents that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink."
},
{
"NDCCode": "81279-121-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (81279-121-60) ",
"NDC11Code": "81279-0121-60",
"ProductNDC": "81279-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bucapsol",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218628",
"LabelerName": "PANGEA PHARMACEUTICALS, LLC",
"SubstanceName": "BUSPIRONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"SamplePackage": "N",
"IndicationAndUsage": "Bucapsol TMcapsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Bucapsol TMcapsules are antianxiety agents that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>81279-117-88</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (81279-117-88) </PackageDescription>
<NDC11Code>81279-0117-88</NDC11Code>
<ProductNDC>81279-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. Each tablet, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>81279-117-60</NDCCode>
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<ProductNDC>81279-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
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<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.</IndicationAndUsage>
<Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α,-methylpregna-1,4-diene-3,20-dione. The structural formula is represented below. C 22H 29FO 5 MW 392.47. DEXLYT TM, for oral administration, contains 0.25 mgof dexamethasone. Each tablet contains the following inactive ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, stearic acid and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>57664-117-88</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57664-117-88) </PackageDescription>
<NDC11Code>57664-0117-88</NDC11Code>
<ProductNDC>57664-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<EndMarketingDate>20201130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090529</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120101</StartMarketingDatePackage>
<EndMarketingDatePackage>20201130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72344-117-03</NDCCode>
<PackageDescription>88 mL in 1 TUBE (72344-117-03) </PackageDescription>
<NDC11Code>72344-0117-03</NDC11Code>
<ProductNDC>72344-117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Surface Sun Spf 50 Dry Touch Fragrance Free</ProprietaryName>
<NonProprietaryName>Homosalate 10.00% Octocrylene 6.00% Avobenzone 3.00%</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Surface Products Corp</LabelerName>
<SubstanceName>HOMOSALATE; OCTOCRYLENE; AVOBENZONE</SubstanceName>
<StrengthNumber>10; 6; 3</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn higher SPF gives more sun protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72476-117-21</NDCCode>
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<NDC11Code>72476-0117-21</NDC11Code>
<ProductNDC>72476-117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
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<EndMarketingDate>20260217</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Retail Business Services, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211130</StartMarketingDatePackage>
<EndMarketingDatePackage>20260217</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73102-117-03</NDCCode>
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<ProductNDC>73102-117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minted Leaf Heat Therapy Relief Roll-on</ProprietaryName>
<NonProprietaryName>Capsaicin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>MMG Consumer Brands, LLC</LabelerName>
<SubstanceName>CAPSAICIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis. simple backache. sprains. bruises and strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76209-117-03</NDCCode>
<PackageDescription>88.7 mL in 1 BOTTLE, SPRAY (76209-117-03) </PackageDescription>
<NDC11Code>76209-0117-03</NDC11Code>
<ProductNDC>76209-117</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Market America Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210311</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Market America, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For hand sanitizing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81279-100-50</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (81279-100-50) / 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>81279-0100-50</NDC11Code>
<ProductNDC>81279-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Florafol Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops</ProprietaryName>
<NonProprietaryName>Vitamin A (as Retinyl Palmitate) Vitamin C (as Ascorbic Acid) Vitamin D3 (as Cholecalciferol) Vitamin E (as D-alpha-tocopherol Acetate) Vitamin B1 (as Thiamine Hcl) Vitamin B2 (as Riboflavin Phosphate Sodium) Niacin (as Niacinamide) Vitamin B6 (pyridoxine Hcl) Folate (as 69 Mcg Quatrefolic ((6s)-5 Methyltetrahydrofolate, Glucosamine Salt, Molar Equivalent To 37.5 Mcg Of Folic Acid)) Vitamin B12 (as Cyanocobalamin) Fluoride (as Sodium Fluoride)</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE</SubstanceName>
<StrengthNumber>3.35; 36; 10; 2; 117; 4; .4; .6; .25; .5; 450</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Florafol Pediatric 0.25 mg/mL Fluoride, is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81279-101-50</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (81279-101-50) / 50 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>81279-0101-50</NDC11Code>
<ProductNDC>81279-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Florafol Fe Pediatric 0.25 Mg/ml Multivitamin And Fluoride Liquid Drops</ProprietaryName>
<NonProprietaryName>Vitamin A (as Retinyl Palmitate) Vitamin C (as Ascorbic Acid) Vitamin D3 (as Cholecalciferol) Vitamin E (as D-alpha-tocopherol Acetate) Vitamin B1 (as Thiamine Hcl) Vitamin B2 (as Riboflavin Phosphate Sodium) Niacin (as Niacinamide) Vitamin B6 (pyridoxine Hcl) Folate (as 69 Mcg Quatrefolic ((6s)-5 Methyltetrahydrofolate, Glucosamine Salt, Molar Equivalent To 37.5 Mcg Of Folic Acid)) Vitamin B12 (as Cyanocobalamin) Iron (as Ferrous Sulfate) Fluoride (as Sodium Fluoride)</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS SULFATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE</SubstanceName>
<StrengthNumber>3.35; 36; 10; 2; 9.5; 117; 4; .4; .6; .25; .5; 450</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; ug/mL; ug/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Florafol FE Pediatric 0.25 mg/mL Fluoride (with Iron), is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81279-133-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (81279-133-10) / 2.5 mg in 1 BOTTLE</PackageDescription>
<NDC11Code>81279-0133-10</NDC11Code>
<ProductNDC>81279-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sdamlo</ProprietaryName>
<NonProprietaryName>Amlodipine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219531</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/2.5mg</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Sdamlo is supplied as a white to off-white powder or powder cake packaged in a unit-dose, single-use container. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively, and the following inactive ingredients: mannitol and neotame. Sdamlo is for oral administration after reconstitution with water [see Dosage and Administration (2.3)] .</Description>
</NDC>
<NDC>
<NDCCode>81279-134-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (81279-134-10) / 5 mg in 1 BOTTLE</PackageDescription>
<NDC11Code>81279-0134-10</NDC11Code>
<ProductNDC>81279-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sdamlo</ProprietaryName>
<NonProprietaryName>Amlodipine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219531</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mg</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Sdamlo is supplied as a white to off-white powder or powder cake packaged in a unit-dose, single-use container. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively, and the following inactive ingredients: mannitol and neotame. Sdamlo is for oral administration after reconstitution with water [see Dosage and Administration (2.3)] .</Description>
</NDC>
<NDC>
<NDCCode>81279-135-10</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLE</PackageDescription>
<NDC11Code>81279-0135-10</NDC11Code>
<ProductNDC>81279-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sdamlo</ProprietaryName>
<NonProprietaryName>Amlodipine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219531</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mg</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sdamlo contains the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25CIN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Sdamlo is supplied as a white to off-white powder or powder cake packaged in a unit-dose, single-use container. Each vial of Sdamlo contains 2.5, 5, and 10 mg of amlodipine, provided as 3.47, 6.94, and 13.88 mg of amlodipine besylate, respectively, and the following inactive ingredients: mannitol and neotame. Sdamlo is for oral administration after reconstitution with water [see Dosage and Administration (2.3)] .</Description>
</NDC>
<NDC>
<NDCCode>54348-117-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-00) > 1 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-00</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-02) > 2 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-02</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-03) > 3 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-03</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-04) > 4 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-04</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-05) > 5 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-05</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-06) > 6 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-06</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-08) > 8 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-08</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-09</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-09) > 9 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-09</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-10) > 10 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-10</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>54348-117-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-117-12) > 12 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0117-12</NDC11Code>
<ProductNDC>54348-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine</ProprietaryName>
<NonProprietaryName>Promethazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040712</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride tablets, USP are useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of. anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 12.5 mg promethazine hydrochloride tablet for oral administration contains 12.5 mg promethazine hydrochloride. Each 25 mg promethazine hydrochloride tablet for oral administration contains 25 mg promethazine hydrochloride. Each 50 mg promethazine hydrochloride tablet for oral administration contains 50 mg promethazine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, and methylcellulose. In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet contains FD&C Yellow #6. Promethazine hydrochloride is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>66689-694-88</NDCCode>
<PackageDescription>4000 mL in 1 BOTTLE (66689-694-88) </PackageDescription>
<NDC11Code>66689-0694-88</NDC11Code>
<ProductNDC>66689-694</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040088</ApplicationNumber>
<LabelerName>VistaPharm, LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone hydrochloride oral concentrate contains methadone, an opioid agonist indicated for the: : 1 detoxification treatment of opioid addiction (heroin or other morphine-like drugs). , 2 maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .</IndicationAndUsage>
<Description>Methadone hydrochloride oral concentrate, USP contains methadone, an opioid agonist, and is available as a cherry-flavored liquid concentrate for oral administration. Methadone hydrochloride oral concentrate, USP sugar-free is a dye-free, sugar-free, unflavored liquid concentrate of methadone hydrochloride for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptone hydrochloride. Methadone hydrochloride, USP is a fine white powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in methadone hydrochloride oral concentrate as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and a molecular weight of 345.91. Its structural formula is C21H27NOHCl. Each liquid concentrate contains 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone) per mL and the following inactive ingredients: artificial cherry flavor, sorbic acid, potassium sorbate, FD&C Red No. 40, D&C Red No. 33, poloxamer 188, propylene glycol, glycerin, sucrose, and purified water. Other ingredients of methadone hydrochloride oral concentrate, USP (dye-free, sugar-free, unflavored): citric acid anhydrous, purified water, sodium benzoate.</Description>
</NDC>
<NDC>
<NDCCode>81279-102-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (81279-102-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>81279-0102-30</NDC11Code>
<ProductNDC>81279-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Florafol</ProprietaryName>
<NonProprietaryName>Multivitamin And Fluoride Supplement</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>11.5; 70; 12; 3.5; 250; 12; 1.15; 1; .5; 1; 700</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ng/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81279-103-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (81279-103-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>81279-0103-30</NDC11Code>
<ProductNDC>81279-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Florafol</ProprietaryName>
<NonProprietaryName>Multivitamin And Fluoride Supplement</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE</SubstanceName>
<StrengthNumber>11.5; 70; 12; 3.5; 250; 12; 1.15; 1; 1; 1; 700</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ng/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>81279-104-03</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (81279-104-03) / 3 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>81279-0104-03</NDC11Code>
<ProductNDC>81279-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergomar</ProprietaryName>
<ProprietaryNameSuffix>Sublingual</ProprietaryNameSuffix>
<NonProprietaryName>Ergotamine Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087693</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals LLC</LabelerName>
<SubstanceName>ERGOTAMINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergomar ®is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia".</IndicationAndUsage>
<Description>Ergomar ®Sublingual Tablets. Ergotamine Tartrate Sublingual Tablets USP ... 2 mg. Inactive Ingredients:Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>81279-104-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (81279-104-20) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>81279-0104-20</NDC11Code>
<ProductNDC>81279-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergomar</ProprietaryName>
<ProprietaryNameSuffix>Sublingual</ProprietaryNameSuffix>
<NonProprietaryName>Ergotamine Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087693</ApplicationNumber>
<LabelerName>Pangea Pharmaceuticals LLC</LabelerName>
<SubstanceName>ERGOTAMINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergomar ®is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia".</IndicationAndUsage>
<Description>Ergomar ®Sublingual Tablets. Ergotamine Tartrate Sublingual Tablets USP ... 2 mg. Inactive Ingredients:Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>81279-106-05</NDCCode>
<PackageDescription>5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (81279-106-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (81279-106-01) </PackageDescription>
<NDC11Code>81279-0106-05</NDC11Code>
<ProductNDC>81279-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selenious Acid</ProprietaryName>
<NonProprietaryName>Selenious Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Pangea Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SELENIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Selenium Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.</IndicationAndUsage>
<Description>Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental selenium 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.</Description>
</NDC>
<NDC>
<NDCCode>81279-121-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (81279-121-30) </PackageDescription>
<NDC11Code>81279-0121-30</NDC11Code>
<ProductNDC>81279-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bucapsol</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218628</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>BUSPIRONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bucapsol TMcapsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bucapsol TMcapsules are antianxiety agents that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>81279-121-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (81279-121-60) </PackageDescription>
<NDC11Code>81279-0121-60</NDC11Code>
<ProductNDC>81279-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bucapsol</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218628</ApplicationNumber>
<LabelerName>PANGEA PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>BUSPIRONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bucapsol TMcapsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Bucapsol TMcapsules are antianxiety agents that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2∙HCl is represented by the following structural formula:. Bucapsol TMcapsules are supplied as capsules for oral administration. Bucapsol TMcapsules contains 5 mg, 7.5 mg, 10 mg, or 15 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.8 mg, 9.1 mg, and 13.7 mg of buspirone free base, respectively) in a hard gelatin shell. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The shell consists of black ink, gelatin, titanium dioxide, fd&c blue no. 1 (7.5 mg, 10 mg, and 15 mg), and black iron oxide (10 mg) and is imprinted with edible ink.</Description>
</NDC>
</NDCList>