{
"NDC": [
{
"NDCCode": "65193-144-46",
"PackageDescription": "2 TABLET in 1 BLISTER PACK (65193-144-46)",
"NDC11Code": "65193-0144-46",
"ProductNDC": "65193-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ephed Plus Sinus",
"NonProprietaryName": "Acetaminophen, Pseudoephedrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111018",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "325; 30",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65193-320-46",
"PackageDescription": "2 TABLET in 1 BLISTER PACK (65193-320-46) ",
"NDC11Code": "65193-0320-46",
"ProductNDC": "65193-320",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ephed Asthma",
"NonProprietaryName": "Ephedrine Hydrochloride, Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111213",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111213",
"SamplePackage": "N"
},
{
"NDCCode": "49348-144-46",
"PackageDescription": "14 PATCH in 1 CARTON (49348-144-46) > 24 h in 1 PATCH",
"NDC11Code": "49348-0144-46",
"ProductNDC": "49348-144",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"ProprietaryNameSuffix": "Transdermal System Step 1",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "21",
"StrengthUnit": "mg/24h",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20151102",
"SamplePackage": "N"
},
{
"NDCCode": "0187-1950-05",
"PackageDescription": "144 g in 1 TUBE (0187-1950-05)",
"NDC11Code": "00187-1950-05",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "16729-418-12",
"PackageDescription": "1 KIT in 1 KIT (16729-418-12) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-54) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-46) ",
"NDC11Code": "16729-0418-12",
"ProductNDC": "16729-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20220926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210499",
"LabelerName": "Accord Healthcare Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220926",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid copolymer, methacrylic acid - methyl methacrylate copolymer (1:1). The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1, iron oxide black, iron oxide yellow, shellac, propylene glycol."
},
{
"NDCCode": "31722-658-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (31722-658-31) / 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "31722-0658-31",
"ProductNDC": "31722-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210500",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "31722-680-60",
"PackageDescription": "1 KIT in 1 KIT (31722-680-60) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "31722-0680-60",
"ProductNDC": "31722-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210500",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "33342-350-95",
"PackageDescription": "46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95) ",
"NDC11Code": "33342-0350-95",
"ProductNDC": "33342-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210377",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250627",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid - ethyl acrylate copolymer type A containing Sodium laurylsulfate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion containing Sodium laurylsulfate and Polysorbate 80, triethyl citrate, and talc. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, FD&C Blue No 1, iron oxide black, iron oxide yellow, titanium dioxide. The black imprinting ink contains shellac, propylene glycol, black iron oxide, potassium hydroxide and strong ammonia solution."
},
{
"NDCCode": "33342-579-96",
"PackageDescription": "1 KIT in 1 KIT (33342-579-96) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95) ",
"NDC11Code": "33342-0579-96",
"ProductNDC": "33342-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20250627",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210377",
"LabelerName": "Macleods Pharmaceuticals Limited",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250627",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid - ethyl acrylate copolymer type A containing Sodium laurylsulfate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion containing Sodium laurylsulfate and Polysorbate 80, triethyl citrate, and talc. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, FD&C Blue No 1, iron oxide black, iron oxide yellow, titanium dioxide. The black imprinting ink contains shellac, propylene glycol, black iron oxide, potassium hydroxide and strong ammonia solution."
},
{
"NDCCode": "43547-025-46",
"PackageDescription": "46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46) ",
"NDC11Code": "43547-0025-46",
"ProductNDC": "43547-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210414",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221018",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (methacrylic acid and methyl methacrylate copolymer, and sodium lauryl sulfate), methacrylic acid and ethyl acrylate copolymer dispersion (methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, and polysorbate 80), silicified microcrystalline cellulose, talc, and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, red iron oxide, and titanium dioxide. The black edible ink BLACK SW9008 contains black iron oxide, potassium hydroxide, and shellac."
},
{
"NDCCode": "49967-500-03",
"PackageDescription": "144 g in 1 TUBE (49967-500-03) ",
"NDC11Code": "49967-0500-03",
"ProductNDC": "49967-500",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave Developed With Dermatologists Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170920",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "L'Oreal USA Products Inc.",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170920",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily protects and helps relieve chafed, chapped or cracked skin: 1 temporarily protects minor: ● cuts ● scrapes ● burns, 2 helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "54288-144-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01) ",
"NDC11Code": "54288-0144-10",
"ProductNDC": "54288-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dehydrated Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207987",
"LabelerName": "BPI Labs, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "ABLYSINOL ® is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.",
"Description": "ABLYSINOL (dehydrated alcohol) injection is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. ABLYSINOL is for cardiac septal branch intra-arterial use. It has a molecular formula of C2H6O and a molecular weight of 46.07. Dehydrated Alcohol Injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula."
},
{
"NDCCode": "60687-942-17",
"PackageDescription": "10 TRAY in 1 CASE (60687-942-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-942-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-942-40) ",
"NDC11Code": "60687-0942-17",
"ProductNDC": "60687-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valproic Acid",
"NonProprietaryName": "Valproic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075379",
"LabelerName": "American Health Packaging",
"SubstanceName": "VALPROIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260804",
"SamplePackage": "N",
"IndicationAndUsage": "Valproic acid is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1).",
"Description": "Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic Acid Oral Solution USP is an antiepileptic for oral administration and contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt."
},
{
"NDCCode": "60687-942-77",
"PackageDescription": "4 TRAY in 1 CASE (60687-942-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-942-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-942-40) ",
"NDC11Code": "60687-0942-77",
"ProductNDC": "60687-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valproic Acid",
"NonProprietaryName": "Valproic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075379",
"LabelerName": "American Health Packaging",
"SubstanceName": "VALPROIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260804",
"SamplePackage": "N",
"IndicationAndUsage": "Valproic acid is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1).",
"Description": "Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic Acid Oral Solution USP is an antiepileptic for oral administration and contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt."
},
{
"NDCCode": "64406-007-03",
"PackageDescription": "1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "64406-0007-03",
"ProductNDC": "64406-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tecfidera",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20130327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204063",
"LabelerName": "Biogen Inc.",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130327",
"SamplePackage": "N",
"IndicationAndUsage": "TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. TECFIDERA is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide."
},
{
"NDCCode": "67877-556-46",
"PackageDescription": "46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-46) ",
"NDC11Code": "67877-0556-46",
"ProductNDC": "67877-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210440",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200926",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed- release capsules contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure: Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, polysorbate 80, silicified microcrystalline cellulose, sodium lauryl sulphate, talc, triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 2 and iron oxide yellow.The imprinting ink contains following ingredients: shellac, propylene glycol, strong ammonia solution,black iron oxide, potassium hydroxide, purified water."
},
{
"NDCCode": "67877-557-39",
"PackageDescription": "1 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "67877-0557-39",
"ProductNDC": "67877-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20200926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210440",
"LabelerName": "Ascend Laboratories, LLC",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200926",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed- release capsules contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure: Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, polysorbate 80, silicified microcrystalline cellulose, sodium lauryl sulphate, talc, triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 2 and iron oxide yellow.The imprinting ink contains following ingredients: shellac, propylene glycol, strong ammonia solution,black iron oxide, potassium hydroxide, purified water."
},
{
"NDCCode": "68180-778-13",
"PackageDescription": "1 KIT in 1 KIT (68180-778-13) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "68180-0778-13",
"ProductNDC": "68180-778",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20201031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210226",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201031",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsule contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, silicified microcrystalline cellulose, talc and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: black iron oxide, D & C yellow 10, FD & C yellow 6, gelatin, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "68462-308-68",
"PackageDescription": "46 CAPSULE in 1 BOTTLE (68462-308-68) ",
"NDC11Code": "68462-0308-68",
"ProductNDC": "68462-308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl-fumarate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210309",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl Fumarate Delayed-Release Capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is sparingly soluble in methanol; insoluble in water with a molecular mass of 144.13. Dimethyl Fumarate Delayed-Release Capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: croscarmellose sodium, hydrophobic colloidal silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, methacrylic acid copolymer dispersion (Eudragit L30 D-55), microcrystalline cellulose, simethicone (30% emulsion), talc and triethyl citrate. Eudragit L30 D-55 has the following ingredients: copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulphate, polysorbate 80 and purified water. The capsule shell for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg contains gelatin, titanium dioxide, FD&C blue 1, iron oxide yellow and iron oxide black. The imprinting ink for Dimethyl Fumarate Delayed-Release Capsule, 120 mg and 240 mg has the following components: black iron oxide, potassium hydroxide, and shellac."
},
{
"NDCCode": "68462-570-78",
"PackageDescription": "1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE",
"NDC11Code": "68462-0570-78",
"ProductNDC": "68462-570",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20201006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210309",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201006",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl Fumarate Delayed-Release Capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is sparingly soluble in methanol; insoluble in water with a molecular mass of 144.13. Dimethyl Fumarate Delayed-Release Capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: croscarmellose sodium, hydrophobic colloidal silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, methacrylic acid copolymer dispersion (Eudragit L30 D-55), microcrystalline cellulose, simethicone (30% emulsion), talc and triethyl citrate. Eudragit L30 D-55 has the following ingredients: copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulphate, polysorbate 80 and purified water. The capsule shell for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg contains gelatin, titanium dioxide, FD&C blue 1, iron oxide yellow and iron oxide black. The imprinting ink for Dimethyl Fumarate Delayed-Release Capsule, 120 mg and 240 mg has the following components: black iron oxide, potassium hydroxide, and shellac."
},
{
"NDCCode": "69097-552-03",
"PackageDescription": "1 KIT in 1 KIT (69097-552-03) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69097-0552-03",
"ProductNDC": "69097-552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210305",
"LabelerName": "Cipla USA Inc.",
"Status": "Active",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is very slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, simethicon emulsion, sodium lauryl sulphate and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1, yellow iron oxide, black iron oxide, shellac, propylene glycol, strong ammonia solution and potassium hydroxide. ."
},
{
"NDCCode": "69539-240-18",
"PackageDescription": "1 KIT in 1 KIT (69539-240-18) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "69539-0240-18",
"ProductNDC": "69539-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20210520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210460",
"LabelerName": "MSN LABORATORIES PRIVATE LIMITED",
"Status": "Active",
"LastUpdate": "2021-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210520",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsule contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is freely soluble in dichloromethane and very slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, methacrylic acid methyl methacrylate copolymer, microcrystalline cellulose, polysorbate 80, sodium lauryl sulfate, talc and triethyl citrate. The capsule shell contains the following inactive ingredients: gelatin and titanium dioxide and is imprinted with black ink, Black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "70710-1205-8",
"PackageDescription": "46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-8) ",
"NDC11Code": "70710-1205-08",
"ProductNDC": "70710-1205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210538",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200928",
"SamplePackage": "Y",
"IndicationAndUsage": "Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is soluble in methanol and slightly soluble in water with a molecular mass of 144.13. Each dimethyl fumarate delayed-release capsule intended for oral administration contains 120 mg or 240 mg dimethyl fumarate respectively and contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer (Type A), methacrylic acid copolymer dispersion (Type C), mono and di-glycerides, povidone, polysorbate 80, sodium lauryl sulphate, talc and triethyl citrate. The capsule shell contains following inactive ingredients: D&C Yellow#10, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide. The capsule shell is imprinted with black pharmaceutical ink and contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "70710-1416-3",
"PackageDescription": "1 KIT in 1 KIT (70710-1416-3) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "70710-1416-03",
"ProductNDC": "70710-1416",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20200928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210538",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200928",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is soluble in methanol and slightly soluble in water with a molecular mass of 144.13. Each dimethyl fumarate delayed-release capsule intended for oral administration contains 120 mg or 240 mg dimethyl fumarate respectively and contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer (Type A), methacrylic acid copolymer dispersion (Type C), mono and di-glycerides, povidone, polysorbate 80, sodium lauryl sulphate, talc and triethyl citrate. The capsule shell contains following inactive ingredients: D&C Yellow#10, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide. The capsule shell is imprinted with black pharmaceutical ink and contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "65193-125-48",
"PackageDescription": "48 TABLET in 1 BLISTER PACK (65193-125-48) ",
"NDC11Code": "65193-0125-48",
"ProductNDC": "65193-125",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Red Label Ephedrine Plus",
"NonProprietaryName": "Ephedrine Hydrochloride, Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190402",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "12.5; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190402",
"SamplePackage": "N",
"IndicationAndUsage": " for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive."
},
{
"NDCCode": "65193-180-57",
"PackageDescription": "60 mL in 1 BOTTLE (65193-180-57) ",
"NDC11Code": "65193-0180-57",
"ProductNDC": "65193-180",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ephed Plus Liquid",
"NonProprietaryName": "Ephedrine Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 400",
"StrengthUnit": "mg/60mL; mg/60mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171110",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for temporary relief of mild symptoms of intermittent asthma: wheezingtightness of chest , shortness of breath , helps loosen phlegm (mucus) and thinbronchial secretions to rid bronchial passageways of bothersome mucus, and to makecoughs more productive."
},
{
"NDCCode": "65193-225-24",
"PackageDescription": "24 TABLET in 1 BLISTER PACK (65193-225-24) ",
"NDC11Code": "65193-0225-24",
"ProductNDC": "65193-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ephed Plus",
"NonProprietaryName": "Ephedrine Hydrochloride, Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190402",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190402",
"SamplePackage": "N",
"IndicationAndUsage": " for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive."
},
{
"NDCCode": "65193-320-19",
"PackageDescription": "6 TABLET in 1 BLISTER PACK (65193-320-19) ",
"NDC11Code": "65193-0320-19",
"ProductNDC": "65193-320",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ephed Asthma",
"NonProprietaryName": "Ephedrine Hydrochloride, Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111213",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111213",
"SamplePackage": "N"
},
{
"NDCCode": "65193-320-24",
"PackageDescription": "24 TABLET in 1 BLISTER PACK (65193-320-24) ",
"NDC11Code": "65193-0320-24",
"ProductNDC": "65193-320",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ephed Asthma",
"NonProprietaryName": "Ephedrine Hydrochloride, Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111213",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "EPHEDRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20111213",
"SamplePackage": "N",
"IndicationAndUsage": " for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive."
},
{
"NDCCode": "65193-325-24",
"PackageDescription": "24 TABLET in 1 BLISTER PACK (65193-325-24) ",
"NDC11Code": "65193-0325-24",
"ProductNDC": "65193-325",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pseudo Ephed Plus",
"NonProprietaryName": "Pseudoephedrine Hydrochloride, Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dickey Consumer Products DBA DMD",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "200; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190315",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves nasal congestion due to the common cold promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive."
}
]
}
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<NDCList>
<NDC>
<NDCCode>65193-144-46</NDCCode>
<PackageDescription>2 TABLET in 1 BLISTER PACK (65193-144-46)</PackageDescription>
<NDC11Code>65193-0144-46</NDC11Code>
<ProductNDC>65193-144</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ephed Plus Sinus</ProprietaryName>
<NonProprietaryName>Acetaminophen, Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65193-320-46</NDCCode>
<PackageDescription>2 TABLET in 1 BLISTER PACK (65193-320-46) </PackageDescription>
<NDC11Code>65193-0320-46</NDC11Code>
<ProductNDC>65193-320</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ephed Asthma</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49348-144-46</NDCCode>
<PackageDescription>14 PATCH in 1 CARTON (49348-144-46) > 24 h in 1 PATCH</PackageDescription>
<NDC11Code>49348-0144-46</NDC11Code>
<ProductNDC>49348-144</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<ProprietaryNameSuffix>Transdermal System Step 1</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Strategic Sourcing Services LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0187-1950-05</NDCCode>
<PackageDescription>144 g in 1 TUBE (0187-1950-05)</PackageDescription>
<NDC11Code>00187-1950-05</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16729-418-12</NDCCode>
<PackageDescription>1 KIT in 1 KIT (16729-418-12) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-416-54) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-46) </PackageDescription>
<NDC11Code>16729-0418-12</NDC11Code>
<ProductNDC>16729-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20220926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210499</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid copolymer, methacrylic acid - methyl methacrylate copolymer (1:1). The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1, iron oxide black, iron oxide yellow, shellac, propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>31722-658-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (31722-658-31) / 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0658-31</NDC11Code>
<ProductNDC>31722-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210500</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-680-60</NDCCode>
<PackageDescription>1 KIT in 1 KIT (31722-680-60) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0680-60</NDC11Code>
<ProductNDC>31722-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210500</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>33342-350-95</NDCCode>
<PackageDescription>46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95) </PackageDescription>
<NDC11Code>33342-0350-95</NDC11Code>
<ProductNDC>33342-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210377</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid - ethyl acrylate copolymer type A containing Sodium laurylsulfate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion containing Sodium laurylsulfate and Polysorbate 80, triethyl citrate, and talc. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, FD&C Blue No 1, iron oxide black, iron oxide yellow, titanium dioxide. The black imprinting ink contains shellac, propylene glycol, black iron oxide, potassium hydroxide and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>33342-579-96</NDCCode>
<PackageDescription>1 KIT in 1 KIT (33342-579-96) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94) * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-350-95) </PackageDescription>
<NDC11Code>33342-0579-96</NDC11Code>
<ProductNDC>33342-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250627</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210377</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid - ethyl acrylate copolymer type A containing Sodium laurylsulfate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion containing Sodium laurylsulfate and Polysorbate 80, triethyl citrate, and talc. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, FD&C Blue No 1, iron oxide black, iron oxide yellow, titanium dioxide. The black imprinting ink contains shellac, propylene glycol, black iron oxide, potassium hydroxide and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>43547-025-46</NDCCode>
<PackageDescription>46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46) </PackageDescription>
<NDC11Code>43547-0025-46</NDC11Code>
<ProductNDC>43547-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210414</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate, USP is a white to off-white powder that is slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (methacrylic acid and methyl methacrylate copolymer, and sodium lauryl sulfate), methacrylic acid and ethyl acrylate copolymer dispersion (methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, and polysorbate 80), silicified microcrystalline cellulose, talc, and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, red iron oxide, and titanium dioxide. The black edible ink BLACK SW9008 contains black iron oxide, potassium hydroxide, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>49967-500-03</NDCCode>
<PackageDescription>144 g in 1 TUBE (49967-500-03) </PackageDescription>
<NDC11Code>49967-0500-03</NDC11Code>
<ProductNDC>49967-500</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave Developed With Dermatologists Healing</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170920</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc.</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily protects and helps relieve chafed, chapped or cracked skin: 1 temporarily protects minor: ● cuts ● scrapes ● burns, 2 helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54288-144-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01) </PackageDescription>
<NDC11Code>54288-0144-10</NDC11Code>
<ProductNDC>54288-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dehydrated Alcohol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS</RouteName>
<StartMarketingDate>20250401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207987</ApplicationNumber>
<LabelerName>BPI Labs, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABLYSINOL ® is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.</IndicationAndUsage>
<Description>ABLYSINOL (dehydrated alcohol) injection is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. ABLYSINOL is for cardiac septal branch intra-arterial use. It has a molecular formula of C2H6O and a molecular weight of 46.07. Dehydrated Alcohol Injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>60687-942-17</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (60687-942-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-942-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-942-40) </PackageDescription>
<NDC11Code>60687-0942-17</NDC11Code>
<ProductNDC>60687-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valproic Acid</ProprietaryName>
<NonProprietaryName>Valproic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075379</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>VALPROIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valproic acid is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1).</IndicationAndUsage>
<Description>Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic Acid Oral Solution USP is an antiepileptic for oral administration and contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt.</Description>
</NDC>
<NDC>
<NDCCode>60687-942-77</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-942-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-942-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-942-40) </PackageDescription>
<NDC11Code>60687-0942-77</NDC11Code>
<ProductNDC>60687-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valproic Acid</ProprietaryName>
<NonProprietaryName>Valproic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075379</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>VALPROIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valproic acid is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1).</IndicationAndUsage>
<Description>Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic Acid Oral Solution USP is an antiepileptic for oral administration and contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt.</Description>
</NDC>
<NDC>
<NDCCode>64406-007-03</NDCCode>
<PackageDescription>1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>64406-0007-03</NDC11Code>
<ProductNDC>64406-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tecfidera</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204063</ApplicationNumber>
<LabelerName>Biogen Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. TECFIDERA is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-556-46</NDCCode>
<PackageDescription>46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67877-556-46) </PackageDescription>
<NDC11Code>67877-0556-46</NDC11Code>
<ProductNDC>67877-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210440</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed- release capsules contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure: Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, polysorbate 80, silicified microcrystalline cellulose, sodium lauryl sulphate, talc, triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 2 and iron oxide yellow.The imprinting ink contains following ingredients: shellac, propylene glycol, strong ammonia solution,black iron oxide, potassium hydroxide, purified water.</Description>
</NDC>
<NDC>
<NDCCode>67877-557-39</NDCCode>
<PackageDescription>1 KIT in 1 KIT (67877-557-39) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>67877-0557-39</NDC11Code>
<ProductNDC>67877-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210440</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed- release capsules contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure: Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, polysorbate 80, silicified microcrystalline cellulose, sodium lauryl sulphate, talc, triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 2 and iron oxide yellow.The imprinting ink contains following ingredients: shellac, propylene glycol, strong ammonia solution,black iron oxide, potassium hydroxide, purified water.</Description>
</NDC>
<NDC>
<NDCCode>68180-778-13</NDCCode>
<PackageDescription>1 KIT in 1 KIT (68180-778-13) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>68180-0778-13</NDC11Code>
<ProductNDC>68180-778</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210226</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsule contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure:. Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, silicified microcrystalline cellulose, talc and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: black iron oxide, D & C yellow 10, FD & C yellow 6, gelatin, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68462-308-68</NDCCode>
<PackageDescription>46 CAPSULE in 1 BOTTLE (68462-308-68) </PackageDescription>
<NDC11Code>68462-0308-68</NDC11Code>
<ProductNDC>68462-308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl-fumarate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210309</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl Fumarate Delayed-Release Capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is sparingly soluble in methanol; insoluble in water with a molecular mass of 144.13. Dimethyl Fumarate Delayed-Release Capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: croscarmellose sodium, hydrophobic colloidal silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, methacrylic acid copolymer dispersion (Eudragit L30 D-55), microcrystalline cellulose, simethicone (30% emulsion), talc and triethyl citrate. Eudragit L30 D-55 has the following ingredients: copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulphate, polysorbate 80 and purified water. The capsule shell for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg contains gelatin, titanium dioxide, FD&C blue 1, iron oxide yellow and iron oxide black. The imprinting ink for Dimethyl Fumarate Delayed-Release Capsule, 120 mg and 240 mg has the following components: black iron oxide, potassium hydroxide, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-570-78</NDCCode>
<PackageDescription>1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0570-78</NDC11Code>
<ProductNDC>68462-570</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210309</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl Fumarate Delayed-Release Capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is sparingly soluble in methanol; insoluble in water with a molecular mass of 144.13. Dimethyl Fumarate Delayed-Release Capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: croscarmellose sodium, hydrophobic colloidal silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, methacrylic acid copolymer dispersion (Eudragit L30 D-55), microcrystalline cellulose, simethicone (30% emulsion), talc and triethyl citrate. Eudragit L30 D-55 has the following ingredients: copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulphate, polysorbate 80 and purified water. The capsule shell for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg contains gelatin, titanium dioxide, FD&C blue 1, iron oxide yellow and iron oxide black. The imprinting ink for Dimethyl Fumarate Delayed-Release Capsule, 120 mg and 240 mg has the following components: black iron oxide, potassium hydroxide, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>69097-552-03</NDCCode>
<PackageDescription>1 KIT in 1 KIT (69097-552-03) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69097-0552-03</NDC11Code>
<ProductNDC>69097-552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210305</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is very slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, simethicon emulsion, sodium lauryl sulphate and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1, yellow iron oxide, black iron oxide, shellac, propylene glycol, strong ammonia solution and potassium hydroxide. .</Description>
</NDC>
<NDC>
<NDCCode>69539-240-18</NDCCode>
<PackageDescription>1 KIT in 1 KIT (69539-240-18) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>69539-0240-18</NDC11Code>
<ProductNDC>69539-240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210460</ApplicationNumber>
<LabelerName>MSN LABORATORIES PRIVATE LIMITED</LabelerName>
<Status>Active</Status>
<LastUpdate>2021-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsule contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is freely soluble in dichloromethane and very slightly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, methacrylic acid methyl methacrylate copolymer, microcrystalline cellulose, polysorbate 80, sodium lauryl sulfate, talc and triethyl citrate. The capsule shell contains the following inactive ingredients: gelatin and titanium dioxide and is imprinted with black ink, Black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>70710-1205-8</NDCCode>
<PackageDescription>46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-8) </PackageDescription>
<NDC11Code>70710-1205-08</NDC11Code>
<ProductNDC>70710-1205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210538</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200928</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is soluble in methanol and slightly soluble in water with a molecular mass of 144.13. Each dimethyl fumarate delayed-release capsule intended for oral administration contains 120 mg or 240 mg dimethyl fumarate respectively and contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer (Type A), methacrylic acid copolymer dispersion (Type C), mono and di-glycerides, povidone, polysorbate 80, sodium lauryl sulphate, talc and triethyl citrate. The capsule shell contains following inactive ingredients: D&C Yellow#10, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide. The capsule shell is imprinted with black pharmaceutical ink and contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>70710-1416-3</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70710-1416-3) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>70710-1416-03</NDC11Code>
<ProductNDC>70710-1416</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210538</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is soluble in methanol and slightly soluble in water with a molecular mass of 144.13. Each dimethyl fumarate delayed-release capsule intended for oral administration contains 120 mg or 240 mg dimethyl fumarate respectively and contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer (Type A), methacrylic acid copolymer dispersion (Type C), mono and di-glycerides, povidone, polysorbate 80, sodium lauryl sulphate, talc and triethyl citrate. The capsule shell contains following inactive ingredients: D&C Yellow#10, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide. The capsule shell is imprinted with black pharmaceutical ink and contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>65193-125-48</NDCCode>
<PackageDescription>48 TABLET in 1 BLISTER PACK (65193-125-48) </PackageDescription>
<NDC11Code>65193-0125-48</NDC11Code>
<ProductNDC>65193-125</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Red Label Ephedrine Plus</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190402</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>12.5; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65193-180-57</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (65193-180-57) </PackageDescription>
<NDC11Code>65193-0180-57</NDC11Code>
<ProductNDC>65193-180</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ephed Plus Liquid</ProprietaryName>
<NonProprietaryName>Ephedrine Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>25; 400</StrengthNumber>
<StrengthUnit>mg/60mL; mg/60mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for temporary relief of mild symptoms of intermittent asthma: wheezingtightness of chest , shortness of breath , helps loosen phlegm (mucus) and thinbronchial secretions to rid bronchial passageways of bothersome mucus, and to makecoughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65193-225-24</NDCCode>
<PackageDescription>24 TABLET in 1 BLISTER PACK (65193-225-24) </PackageDescription>
<NDC11Code>65193-0225-24</NDC11Code>
<ProductNDC>65193-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ephed Plus</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190402</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65193-320-19</NDCCode>
<PackageDescription>6 TABLET in 1 BLISTER PACK (65193-320-19) </PackageDescription>
<NDC11Code>65193-0320-19</NDC11Code>
<ProductNDC>65193-320</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ephed Asthma</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65193-320-24</NDCCode>
<PackageDescription>24 TABLET in 1 BLISTER PACK (65193-320-24) </PackageDescription>
<NDC11Code>65193-0320-24</NDC11Code>
<ProductNDC>65193-320</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ephed Asthma</ProprietaryName>
<NonProprietaryName>Ephedrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>EPHEDRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65193-325-24</NDCCode>
<PackageDescription>24 TABLET in 1 BLISTER PACK (65193-325-24) </PackageDescription>
<NDC11Code>65193-0325-24</NDC11Code>
<ProductNDC>65193-325</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pseudo Ephed Plus</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dickey Consumer Products DBA DMD</LabelerName>
<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves nasal congestion due to the common cold promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.</IndicationAndUsage>
</NDC>
</NDCList>