{
"NDC": [
{
"NDCCode": "49348-315-84",
"PackageDescription": "1 BOTTLE in 1 CARTON (49348-315-84) > 89 mL in 1 BOTTLE",
"NDC11Code": "49348-0315-84",
"ProductNDC": "49348-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120828",
"SamplePackage": "N"
},
{
"NDCCode": "10544-315-84",
"PackageDescription": "84 TABLET in 1 BOTTLE (10544-315-84)",
"NDC11Code": "10544-0315-84",
"ProductNDC": "10544-315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040729",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "500; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-05-05"
},
{
"NDCCode": "62217-315-85",
"PackageDescription": "1 CONTAINER in 1 BLISTER PACK (62217-315-85) > 17 g in 1 CONTAINER (62217-315-84) ",
"NDC11Code": "62217-0315-85",
"ProductNDC": "62217-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth",
"ProprietaryNameSuffix": "Sun Town City",
"NonProprietaryName": "Baby Spf 50 Sunscreen Stick",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200212",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Fruit of the Earth, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200212",
"SamplePackage": "N"
},
{
"NDCCode": "49348-039-84",
"PackageDescription": "85 g in 1 TUBE (49348-039-84) ",
"NDC11Code": "49348-0039-84",
"ProductNDC": "49348-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "McKesson",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "340",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N"
},
{
"NDCCode": "49348-100-84",
"PackageDescription": "1 BOTTLE in 1 CARTON (49348-100-84) > 89 mL in 1 BOTTLE",
"NDC11Code": "49348-0100-84",
"ProductNDC": "49348-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130618",
"SamplePackage": "N"
},
{
"NDCCode": "49348-421-84",
"PackageDescription": "1 BOTTLE in 1 CARTON (49348-421-84) > 118 mL in 1 BOTTLE",
"NDC11Code": "49348-0421-84",
"ProductNDC": "49348-421",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Adult Tussin",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130813",
"EndMarketingDate": "20200430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/10mL; mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130813",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "49348-426-84",
"PackageDescription": "1 TUBE in 1 CARTON (49348-426-84) > 85 g in 1 TUBE",
"NDC11Code": "49348-0426-84",
"ProductNDC": "49348-426",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Muscle Rub",
"NonProprietaryName": "Menthol, Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131103",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "10; 15",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131103",
"SamplePackage": "N"
},
{
"NDCCode": "49348-883-84",
"PackageDescription": "1 TUBE in 1 CARTON (49348-883-84) > 85 g in 1 TUBE",
"NDC11Code": "49348-0883-84",
"ProductNDC": "49348-883",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Arthricream Rub",
"NonProprietaryName": "Trolamine Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090610",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises."
},
{
"NDCCode": "0093-9609-95",
"PackageDescription": "1 TUBE in 1 CARTON (0093-9609-95) / 45 g in 1 TUBE",
"NDC11Code": "00093-9609-95",
"ProductNDC": "0093-9609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215408",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see DOSAGE AND ADMINISTRATION).",
"Description": "Doxepin hydrochloride cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride, USP (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-∆11(6H),γ-propylaminehydrochloride. Doxepin hydrochloride, USP has a molecular formula of C19H21NOHCl and a molecular weight of 315.84. Doxepin hydrochloride cream, 5% is a white cream and contains the following inactive ingredients: sorbitol solution, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, white petrolatum, benzyl alcohol, titanium dioxide, and purified water."
},
{
"NDCCode": "0228-3315-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0228-3315-03) ",
"NDC11Code": "00228-3315-03",
"ProductNDC": "0228-3315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201951",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride USP, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, and titanium dioxide. The 3 mg tablet also contains polyethylene glycol 400. The 6 mg tablet also contains FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake (Sunset Yellow Lake), and triacetin."
},
{
"NDCCode": "0228-3316-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03) ",
"NDC11Code": "00228-3316-03",
"ProductNDC": "0228-3316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201951",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride USP, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, and titanium dioxide. The 3 mg tablet also contains polyethylene glycol 400. The 6 mg tablet also contains FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake (Sunset Yellow Lake), and triacetin."
},
{
"NDCCode": "0378-1049-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-01) ",
"NDC11Code": "00378-1049-01",
"ProductNDC": "0378-1049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-1049-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-10) ",
"NDC11Code": "00378-1049-10",
"ProductNDC": "0378-1049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-3125-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01) ",
"NDC11Code": "00378-3125-01",
"ProductNDC": "0378-3125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-3125-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10) ",
"NDC11Code": "00378-3125-10",
"ProductNDC": "0378-3125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-4250-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-01) ",
"NDC11Code": "00378-4250-01",
"ProductNDC": "0378-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-4250-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-10) ",
"NDC11Code": "00378-4250-10",
"ProductNDC": "0378-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-4810-93",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0378-4810-93) ",
"NDC11Code": "00378-4810-93",
"ProductNDC": "0378-4810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022036",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200102",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)].",
"Description": "Doxepin hydrochloride tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19 H21 NOHCl. Each doxepin hydrochloride tablet includes the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No.1. The 6 mg tablet also contains D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "0378-4811-93",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0378-4811-93) ",
"NDC11Code": "00378-4811-93",
"ProductNDC": "0378-4811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200102",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022036",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200102",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)].",
"Description": "Doxepin hydrochloride tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19 H21 NOHCl. Each doxepin hydrochloride tablet includes the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No.1. The 6 mg tablet also contains D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "0378-5375-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-01) ",
"NDC11Code": "00378-5375-01",
"ProductNDC": "0378-5375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-5375-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-10) ",
"NDC11Code": "00378-5375-10",
"ProductNDC": "0378-5375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-6410-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-01) ",
"NDC11Code": "00378-6410-01",
"ProductNDC": "0378-6410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "0378-6410-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-10) ",
"NDC11Code": "00378-6410-10",
"ProductNDC": "0378-6410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070791",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860513",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"NDCCode": "10135-758-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30) ",
"NDC11Code": "10135-0758-30",
"ProductNDC": "10135-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202337",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1-propanamine, 3-dibenz[ b,e]oxepin-11(6 H)ylidene- N, N-dimethyl-hydrochloride. It has the following structure:. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of. C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "10135-764-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (10135-764-30) ",
"NDC11Code": "10135-0764-30",
"ProductNDC": "10135-764",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202337",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1-propanamine, 3-dibenz[ b,e]oxepin-11(6 H)ylidene- N, N-dimethyl-hydrochloride. It has the following structure:. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of. C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "16714-132-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-132-01) ",
"NDC11Code": "16714-0132-01",
"ProductNDC": "16714-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213063",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201012",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "16714-133-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-133-01) ",
"NDC11Code": "16714-0133-01",
"ProductNDC": "16714-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213063",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
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"LastUpdate": "2025-11-04",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "16714-134-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-134-01) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e] oxepin-11 (6H )ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze."
},
{
"NDCCode": "16714-135-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-135-01) ",
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"ProductNDC": "16714-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze."
},
{
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"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-136-01) ",
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"ProductNDC": "16714-136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213063",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze."
}
]
}
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<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
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<LastUpdate>2014-05-05</LastUpdate>
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<PackageDescription>1 CONTAINER in 1 BLISTER PACK (62217-315-85) > 17 g in 1 CONTAINER (62217-315-84) </PackageDescription>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<LabelerName>McKesson</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Status>Deprecated</Status>
<LastUpdate>2022-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>1 BOTTLE in 1 CARTON (49348-421-84) > 118 mL in 1 BOTTLE</PackageDescription>
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<ApplicationNumber>part341</ApplicationNumber>
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<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130813</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10; 15</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
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<LastUpdate>2024-10-12</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor pain associated with: 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises.</IndicationAndUsage>
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<NDC>
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<StartMarketingDate>20230217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215408</ApplicationNumber>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Doxepin hydrochloride cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride, USP (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-∆11(6H),γ-propylaminehydrochloride. Doxepin hydrochloride, USP has a molecular formula of C19H21NOHCl and a molecular weight of 315.84. Doxepin hydrochloride cream, 5% is a white cream and contains the following inactive ingredients: sorbitol solution, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, white petrolatum, benzyl alcohol, titanium dioxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0228-3315-03</NDCCode>
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<ProductNDC>0228-3315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201951</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride USP, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, and titanium dioxide. The 3 mg tablet also contains polyethylene glycol 400. The 6 mg tablet also contains FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake (Sunset Yellow Lake), and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0228-3316-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03) </PackageDescription>
<NDC11Code>00228-3316-03</NDC11Code>
<ProductNDC>0228-3316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201951</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride USP, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, and titanium dioxide. The 3 mg tablet also contains polyethylene glycol 400. The 6 mg tablet also contains FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake (Sunset Yellow Lake), and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0378-1049-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-01) </PackageDescription>
<NDC11Code>00378-1049-01</NDC11Code>
<ProductNDC>0378-1049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-1049-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-10) </PackageDescription>
<NDC11Code>00378-1049-10</NDC11Code>
<ProductNDC>0378-1049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-3125-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01) </PackageDescription>
<NDC11Code>00378-3125-01</NDC11Code>
<ProductNDC>0378-3125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-3125-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10) </PackageDescription>
<NDC11Code>00378-3125-10</NDC11Code>
<ProductNDC>0378-3125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-4250-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-01) </PackageDescription>
<NDC11Code>00378-4250-01</NDC11Code>
<ProductNDC>0378-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-4250-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-10) </PackageDescription>
<NDC11Code>00378-4250-10</NDC11Code>
<ProductNDC>0378-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-4810-93</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0378-4810-93) </PackageDescription>
<NDC11Code>00378-4810-93</NDC11Code>
<ProductNDC>0378-4810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022036</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Doxepin hydrochloride tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19 H21 NOHCl. Each doxepin hydrochloride tablet includes the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No.1. The 6 mg tablet also contains D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0378-4811-93</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0378-4811-93) </PackageDescription>
<NDC11Code>00378-4811-93</NDC11Code>
<ProductNDC>0378-4811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022036</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Doxepin hydrochloride tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19 H21 NOHCl. Each doxepin hydrochloride tablet includes the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No.1. The 6 mg tablet also contains D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>0378-5375-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-01) </PackageDescription>
<NDC11Code>00378-5375-01</NDC11Code>
<ProductNDC>0378-5375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-5375-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-10) </PackageDescription>
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<ProductNDC>0378-5375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
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<NDC>
<NDCCode>0378-6410-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-01) </PackageDescription>
<NDC11Code>00378-6410-01</NDC11Code>
<ProductNDC>0378-6410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>0378-6410-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-10) </PackageDescription>
<NDC11Code>00378-6410-10</NDC11Code>
<ProductNDC>0378-6410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070791</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19860513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C19H21NO HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>10135-758-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (10135-758-30) </PackageDescription>
<NDC11Code>10135-0758-30</NDC11Code>
<ProductNDC>10135-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202337</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1-propanamine, 3-dibenz[ b,e]oxepin-11(6 H)ylidene- N, N-dimethyl-hydrochloride. It has the following structure:. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of. C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>10135-764-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (10135-764-30) </PackageDescription>
<NDC11Code>10135-0764-30</NDC11Code>
<ProductNDC>10135-764</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202337</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1-propanamine, 3-dibenz[ b,e]oxepin-11(6 H)ylidene- N, N-dimethyl-hydrochloride. It has the following structure:. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of. C19H21NOHCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>16714-132-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-132-01) </PackageDescription>
<NDC11Code>16714-0132-01</NDC11Code>
<ProductNDC>16714-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213063</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>16714-133-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-133-01) </PackageDescription>
<NDC11Code>16714-0133-01</NDC11Code>
<ProductNDC>16714-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213063</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>16714-134-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-134-01) </PackageDescription>
<NDC11Code>16714-0134-01</NDC11Code>
<ProductNDC>16714-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213063</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[b,e] oxepin-11 (6H )ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>16714-135-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-135-01) </PackageDescription>
<NDC11Code>16714-0135-01</NDC11Code>
<ProductNDC>16714-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213063</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>16714-136-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-136-01) </PackageDescription>
<NDC11Code>16714-0136-01</NDC11Code>
<ProductNDC>16714-136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213063</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety., 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)., 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19H 21NO ∙ HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. It may be represented by the following structural formula:. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e] oxepin-11 (6 H)ylidene- N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg empty gelatin capsule shells contain iron oxide red and iron oxide yellow, the 25 mg and 50 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Yellow 6, and the 75 mg and 100 mg empty gelatin capsule shells contain D&C Yellow 10 and FD&C Blue 1. The imprinting ink may contain ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac glaze.</Description>
</NDC>
</NDCList>