{
"NDC": [
{
"NDCCode": "75816-275-27",
"PackageDescription": "1040988 mL in 1 CONTAINER (75816-275-27) ",
"NDC11Code": "75816-0275-27",
"ProductNDC": "75816-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gel Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75816-175-27",
"PackageDescription": "1040988 mL in 1 CONTAINER (75816-175-27) ",
"NDC11Code": "75816-0175-27",
"ProductNDC": "75816-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Liquid Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75816-375-27",
"PackageDescription": "1040988 mL in 1 CONTAINER (75816-375-27) ",
"NDC11Code": "75816-0375-27",
"ProductNDC": "75816-375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Vera Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "11673-247-27",
"PackageDescription": "275 TABLET in 1 BOTTLE, PLASTIC (11673-247-27) ",
"NDC11Code": "11673-0247-27",
"ProductNDC": "11673-247",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141130",
"EndMarketingDate": "20201130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "TARGET Corporation",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
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"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141130",
"EndMarketingDatePackage": "20201130",
"SamplePackage": "N"
},
{
"NDCCode": "11673-525-27",
"PackageDescription": "275 TABLET in 1 BOTTLE, PLASTIC (11673-525-27) ",
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"ProductNDC": "11673-525",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "Extra Strength",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "TARGET Corporation",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160630",
"EndMarketingDatePackage": "20221230",
"SamplePackage": "N"
},
{
"NDCCode": "75816-275-01",
"PackageDescription": "3785 mL in 1 JUG (75816-275-01) ",
"NDC11Code": "75816-0275-01",
"ProductNDC": "75816-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gel Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75816-275-05",
"PackageDescription": "18927 mL in 1 PAIL (75816-275-05) ",
"NDC11Code": "75816-0275-05",
"ProductNDC": "75816-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gel Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75816-275-06",
"PackageDescription": "177 mL in 1 BOTTLE, DISPENSING (75816-275-06) ",
"NDC11Code": "75816-0275-06",
"ProductNDC": "75816-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gel Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75816-275-32",
"PackageDescription": "946 mL in 1 BOTTLE, DISPENSING (75816-275-32) ",
"NDC11Code": "75816-0275-32",
"ProductNDC": "75816-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gel Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "75816-275-55",
"PackageDescription": "208198 mL in 1 DRUM (75816-275-55) ",
"NDC11Code": "75816-0275-55",
"ProductNDC": "75816-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gel Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Classic Coatings Systems",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0268-0247-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (0268-0247-05) ",
"NDC11Code": "00268-0247-05",
"ProductNDC": "0268-0247",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Histamine Positive",
"ProprietaryNameSuffix": "Skin Test Control",
"NonProprietaryName": "Histamine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "PERCUTANEOUS",
"StartMarketingDate": "19891023",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103754",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "HISTAMINE PHOSPHATE",
"StrengthNumber": "2.75",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2020-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19891023",
"SamplePackage": "N",
"IndicationAndUsage": "For use as a positive control in evaluation of allergenic (immediate hypersensitivity or \"Type I\") skin testing.",
"Description": "The chemical formula for Histamine Phosphate is C5H9 N3 · 2H3 PO4; its molecular weight is 307.14. For prick, puncture or scratch testing, the product is a sterile solution that contains 1 mg/mL histamine base (2.75 mg/mL Histamine Phosphate) in Water for Injection; it also contains Glycerin 50% (v/v) as viscosity agent and Phenol 0.4% as preservative. For intracutaneous (intradermal) skin testing, the product is a sterile solution that contains 0.1 mg/mL histamine base (0.275 mg/mL Histamine Phosphate) in Water for Injection and Phenol 0.4% as preservative. The product should be stored refrigerated and protected from light."
},
{
"NDCCode": "0268-0248-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (0268-0248-05) ",
"NDC11Code": "00268-0248-05",
"ProductNDC": "0268-0248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Histamine Positive",
"ProprietaryNameSuffix": "Skin Test Control",
"NonProprietaryName": "Histamine Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL",
"StartMarketingDate": "19891023",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103754",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "HISTAMINE PHOSPHATE",
"StrengthNumber": ".275",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2020-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19891023",
"SamplePackage": "N",
"IndicationAndUsage": "For use as a positive control in evaluation of allergenic (immediate hypersensitivity or \"Type I\") skin testing.",
"Description": "The chemical formula for Histamine Phosphate is C5H9 N3 · 2H3 PO4; its molecular weight is 307.14. For prick, puncture or scratch testing, the product is a sterile solution that contains 1 mg/mL histamine base (2.75 mg/mL Histamine Phosphate) in Water for Injection; it also contains Glycerin 50% (v/v) as viscosity agent and Phenol 0.4% as preservative. For intracutaneous (intradermal) skin testing, the product is a sterile solution that contains 0.1 mg/mL histamine base (0.275 mg/mL Histamine Phosphate) in Water for Injection and Phenol 0.4% as preservative. The product should be stored refrigerated and protected from light."
},
{
"NDCCode": "11090-275-01",
"PackageDescription": "1 TUBE in 1 CARTON (11090-275-01) / 32 mL in 1 TUBE",
"NDC11Code": "11090-0275-01",
"ProductNDC": "11090-275",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "It Cosmetics Your Skin But Better Cc Plus Nude Glow Color Correcting Medium Coverage Skin Tint Brightening Glow Serum Broad Spectrum Spf 40 Sunscreen - Neutral Tan",
"NonProprietaryName": "Octocrylene, Homosalate, Octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220318",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beauty Manufacturing Solutions Corp.",
"SubstanceName": "HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "83; 45; 56",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220318",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "11673-070-72",
"PackageDescription": "275 TABLET, COATED in 1 BOTTLE (11673-070-72) ",
"NDC11Code": "11673-0070-72",
"ProductNDC": "11673-070",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"NonProprietaryName": "Acetaminophen-aspirin-caffeine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191004",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "ASPIRIN; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200204",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:."
},
{
"NDCCode": "42192-135-10",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (42192-135-10) / 10 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "42192-0135-10",
"ProductNDC": "42192-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111010",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "275",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111010",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "Salicylic Acid, 27.5% Wart Remover is indicated for the topical treatment and removal of common warts and plantar warts.",
"Description": "Salicylic Acid, 27.5% Wart Remover is a topical preparation containing 27.5% salicylic acid in a film-forming vehicle composed of isopropyl alcohol, isobutyrate, acrylates copolymer, N butyl acetate and polyvinyl butyrate. The pharmacologic activity of Salicylic Acid, 27.5% Wart Remover is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is."
},
{
"NDCCode": "42783-312-10",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (42783-312-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "42783-0312-10",
"ProductNDC": "42783-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Virasal",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Elorac, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "275",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20110401",
"SamplePackage": "N",
"IndicationAndUsage": "Virasal is indicated for the topical treatment and removal of common warts and plantar warts.",
"Description": "Virasal is a topical preparation containing 27.5% salicylic acid in a proprietary film-forming vehicle that comprises isopropyl alcohol, butyl acetate, polyvinyl butyral, isopropyl metacresol, trimethyl pentanyl diisobutyrate, phenic acid and acrylates copolymer. The pharmacologic activity of Virasal is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a polyacrylic, film-forming virucidal vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is."
},
{
"NDCCode": "42806-275-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-275-01) ",
"NDC11Code": "42806-0275-01",
"ProductNDC": "42806-275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216235",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 2.Generalized tonic-clonic seizures (grand mal)., 3 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg, tablets of 200 mg, extended-release tablets of 100, 200, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Each Carbamazepine Extended-Release Tablet intended for oral administration contains 100 mg, 200 mg or 400 mg of carbamazepine. In addition, each extended-release tablet contains the following inactive ingredients. Inactive Ingredients: Hypromellose, hydroxyethyl cellulose, cellulose acetate, polyethylene glycol, mannitol, dextrates, sodium lauryl sulfate, and magnesium stearate. Each tablet is printed with Opacode Black S-1-17823 ink which contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. FDA spproved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-725-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-725-30) ",
"NDC11Code": "46708-0725-30",
"ProductNDC": "46708-725",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-725-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-725-90) ",
"NDC11Code": "46708-0725-90",
"ProductNDC": "46708-725",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-725-91",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-725-91) ",
"NDC11Code": "46708-0725-91",
"ProductNDC": "46708-725",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-726-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-30) ",
"NDC11Code": "46708-0726-30",
"ProductNDC": "46708-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-726-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-90) ",
"NDC11Code": "46708-0726-90",
"ProductNDC": "46708-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-726-91",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-91) ",
"NDC11Code": "46708-0726-91",
"ProductNDC": "46708-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-727-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-727-30) ",
"NDC11Code": "46708-0727-30",
"ProductNDC": "46708-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-727-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-727-90) ",
"NDC11Code": "46708-0727-90",
"ProductNDC": "46708-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-727-91",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-727-91) ",
"NDC11Code": "46708-0727-91",
"ProductNDC": "46708-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-728-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-728-30) ",
"NDC11Code": "46708-0728-30",
"ProductNDC": "46708-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-728-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-728-90) ",
"NDC11Code": "46708-0728-90",
"ProductNDC": "46708-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-728-91",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-728-91) ",
"NDC11Code": "46708-0728-91",
"ProductNDC": "46708-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
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"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
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"StrengthUnit": "mg/1",
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"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-729-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-30) ",
"NDC11Code": "46708-0729-30",
"ProductNDC": "46708-729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216968",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241114",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP."
}
]
}
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<PackageDescription>275 TABLET in 1 BOTTLE, PLASTIC (11673-247-27) </PackageDescription>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141130</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>18927 mL in 1 PAIL (75816-275-05) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
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<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
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<NDCCode>75816-275-32</NDCCode>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Classic Coatings Systems</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75816-275-55</NDCCode>
<PackageDescription>208198 mL in 1 DRUM (75816-275-55) </PackageDescription>
<NDC11Code>75816-0275-55</NDC11Code>
<ProductNDC>75816-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gel Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Classic Coatings Systems</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0268-0247-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (0268-0247-05) </PackageDescription>
<NDC11Code>00268-0247-05</NDC11Code>
<ProductNDC>0268-0247</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Histamine Positive</ProprietaryName>
<ProprietaryNameSuffix>Skin Test Control</ProprietaryNameSuffix>
<NonProprietaryName>Histamine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS</RouteName>
<StartMarketingDate>19891023</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103754</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HISTAMINE PHOSPHATE</SubstanceName>
<StrengthNumber>2.75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19891023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.</IndicationAndUsage>
<Description>The chemical formula for Histamine Phosphate is C5H9 N3 · 2H3 PO4; its molecular weight is 307.14. For prick, puncture or scratch testing, the product is a sterile solution that contains 1 mg/mL histamine base (2.75 mg/mL Histamine Phosphate) in Water for Injection; it also contains Glycerin 50% (v/v) as viscosity agent and Phenol 0.4% as preservative. For intracutaneous (intradermal) skin testing, the product is a sterile solution that contains 0.1 mg/mL histamine base (0.275 mg/mL Histamine Phosphate) in Water for Injection and Phenol 0.4% as preservative. The product should be stored refrigerated and protected from light.</Description>
</NDC>
<NDC>
<NDCCode>0268-0248-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (0268-0248-05) </PackageDescription>
<NDC11Code>00268-0248-05</NDC11Code>
<ProductNDC>0268-0248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Histamine Positive</ProprietaryName>
<ProprietaryNameSuffix>Skin Test Control</ProprietaryNameSuffix>
<NonProprietaryName>Histamine Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL</RouteName>
<StartMarketingDate>19891023</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103754</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HISTAMINE PHOSPHATE</SubstanceName>
<StrengthNumber>.275</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2020-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19891023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as a positive control in evaluation of allergenic (immediate hypersensitivity or "Type I") skin testing.</IndicationAndUsage>
<Description>The chemical formula for Histamine Phosphate is C5H9 N3 · 2H3 PO4; its molecular weight is 307.14. For prick, puncture or scratch testing, the product is a sterile solution that contains 1 mg/mL histamine base (2.75 mg/mL Histamine Phosphate) in Water for Injection; it also contains Glycerin 50% (v/v) as viscosity agent and Phenol 0.4% as preservative. For intracutaneous (intradermal) skin testing, the product is a sterile solution that contains 0.1 mg/mL histamine base (0.275 mg/mL Histamine Phosphate) in Water for Injection and Phenol 0.4% as preservative. The product should be stored refrigerated and protected from light.</Description>
</NDC>
<NDC>
<NDCCode>11090-275-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11090-275-01) / 32 mL in 1 TUBE</PackageDescription>
<NDC11Code>11090-0275-01</NDC11Code>
<ProductNDC>11090-275</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>It Cosmetics Your Skin But Better Cc Plus Nude Glow Color Correcting Medium Coverage Skin Tint Brightening Glow Serum Broad Spectrum Spf 40 Sunscreen - Neutral Tan</ProprietaryName>
<NonProprietaryName>Octocrylene, Homosalate, Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220318</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beauty Manufacturing Solutions Corp.</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>83; 45; 56</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-070-72</NDCCode>
<PackageDescription>275 TABLET, COATED in 1 BOTTLE (11673-070-72) </PackageDescription>
<NDC11Code>11673-0070-72</NDC11Code>
<ProductNDC>11673-070</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen-aspirin-caffeine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>ASPIRIN; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42192-135-10</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (42192-135-10) / 10 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>42192-0135-10</NDC11Code>
<ProductNDC>42192-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111010</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>275</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111010</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Salicylic Acid, 27.5% Wart Remover is indicated for the topical treatment and removal of common warts and plantar warts.</IndicationAndUsage>
<Description>Salicylic Acid, 27.5% Wart Remover is a topical preparation containing 27.5% salicylic acid in a film-forming vehicle composed of isopropyl alcohol, isobutyrate, acrylates copolymer, N butyl acetate and polyvinyl butyrate. The pharmacologic activity of Salicylic Acid, 27.5% Wart Remover is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is.</Description>
</NDC>
<NDC>
<NDCCode>42783-312-10</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (42783-312-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>42783-0312-10</NDC11Code>
<ProductNDC>42783-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Virasal</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Elorac, Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>275</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Virasal is indicated for the topical treatment and removal of common warts and plantar warts.</IndicationAndUsage>
<Description>Virasal is a topical preparation containing 27.5% salicylic acid in a proprietary film-forming vehicle that comprises isopropyl alcohol, butyl acetate, polyvinyl butyral, isopropyl metacresol, trimethyl pentanyl diisobutyrate, phenic acid and acrylates copolymer. The pharmacologic activity of Virasal is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a polyacrylic, film-forming virucidal vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is.</Description>
</NDC>
<NDC>
<NDCCode>42806-275-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-275-01) </PackageDescription>
<NDC11Code>42806-0275-01</NDC11Code>
<ProductNDC>42806-275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216235</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 2.Generalized tonic-clonic seizures (grand mal)., 3 3.Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg, tablets of 200 mg, extended-release tablets of 100, 200, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Each Carbamazepine Extended-Release Tablet intended for oral administration contains 100 mg, 200 mg or 400 mg of carbamazepine. In addition, each extended-release tablet contains the following inactive ingredients. Inactive Ingredients: Hypromellose, hydroxyethyl cellulose, cellulose acetate, polyethylene glycol, mannitol, dextrates, sodium lauryl sulfate, and magnesium stearate. Each tablet is printed with Opacode Black S-1-17823 ink which contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. FDA spproved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-725-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-725-30) </PackageDescription>
<NDC11Code>46708-0725-30</NDC11Code>
<ProductNDC>46708-725</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216968</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-725-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-725-90) </PackageDescription>
<NDC11Code>46708-0725-90</NDC11Code>
<ProductNDC>46708-725</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216968</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-725-91</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-725-91) </PackageDescription>
<NDC11Code>46708-0725-91</NDC11Code>
<ProductNDC>46708-725</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216968</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-726-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-726-30) </PackageDescription>
<NDC11Code>46708-0726-30</NDC11Code>
<ProductNDC>46708-726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216968</ApplicationNumber>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216968</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-729-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-30) </PackageDescription>
<NDC11Code>46708-0729-30</NDC11Code>
<ProductNDC>46708-729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216968</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black. The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>