{
"NDC": [
{
"NDCCode": "30142-169-53",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-169-53) > 25 CAPSULE in 1 BOTTLE",
"NDC11Code": "30142-0169-53",
"ProductNDC": "30142-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride (allergy)",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209107",
"LabelerName": "KROGER COMPANY",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210324",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "30142-169-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-169-12) > 40 CAPSULE in 1 BOTTLE",
"NDC11Code": "30142-0169-12",
"ProductNDC": "30142-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride (allergy)",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209107",
"LabelerName": "KROGER COMPANY",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210324",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies."
},
{
"NDCCode": "30142-142-53",
"PackageDescription": "150 g in 1 CAN (30142-142-53) ",
"NDC11Code": "30142-0142-53",
"ProductNDC": "30142-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole Nitrate",
"NonProprietaryName": "Antifungal Liquid Continuous Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Kroger Co.",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2",
"StrengthUnit": "g/150g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris). relieves symptoms of athlete's foot, including itching burning and cracking."
},
{
"NDCCode": "30142-147-53",
"PackageDescription": "150 g in 1 CAN (30142-147-53) ",
"NDC11Code": "30142-0147-53",
"ProductNDC": "30142-147",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tolnaftate",
"NonProprietaryName": "Antifungal Spray Liquid",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Kroger Co.",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "150",
"StrengthUnit": "g/150g",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking."
},
{
"NDCCode": "30142-425-53",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (30142-425-53) > 6 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "30142-0425-53",
"ProductNDC": "30142-425",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexo Fenadine",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Kroger Company",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "30142-555-53",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (30142-555-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "30142-0555-53",
"ProductNDC": "30142-555",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Kroger Company",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20131219",
"SamplePackage": "N"
},
{
"NDCCode": "30142-581-53",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (30142-581-53) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "30142-0581-53",
"ProductNDC": "30142-581",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal Anti Gas",
"NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209837",
"LabelerName": "Kroger Company",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "30142-935-53",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (30142-935-53) > 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "30142-0935-53",
"ProductNDC": "30142-935",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Sinus",
"ProprietaryNameSuffix": "Congestion And Pain",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110731",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "30142-998-53",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (30142-998-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "30142-0998-53",
"ProductNDC": "30142-998",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Kroger Company",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20030307",
"SamplePackage": "N"
},
{
"NDCCode": "27241-167-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-167-01) ",
"NDC11Code": "27241-0167-01",
"ProductNDC": "27241-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-167-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-167-10) ",
"NDC11Code": "27241-0167-10",
"ProductNDC": "27241-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-168-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-168-01) ",
"NDC11Code": "27241-0168-01",
"ProductNDC": "27241-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-168-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-168-10) ",
"NDC11Code": "27241-0168-10",
"ProductNDC": "27241-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-169-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-169-01) ",
"NDC11Code": "27241-0169-01",
"ProductNDC": "27241-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-169-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-169-10) ",
"NDC11Code": "27241-0169-10",
"ProductNDC": "27241-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-170-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-170-01) ",
"NDC11Code": "27241-0170-01",
"ProductNDC": "27241-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-170-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-170-10) ",
"NDC11Code": "27241-0170-10",
"ProductNDC": "27241-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-171-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-171-01) ",
"NDC11Code": "27241-0171-01",
"ProductNDC": "27241-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-171-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-171-10) ",
"NDC11Code": "27241-0171-10",
"ProductNDC": "27241-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200220",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "67046-0394-3",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (67046-0394-3) ",
"NDC11Code": "67046-0394-03",
"ProductNDC": "67046-0394",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Coupler LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260616",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "70518-3594-1",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (70518-3594-1) ",
"NDC11Code": "70518-3594-01",
"ProductNDC": "70518-3594",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250207",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "70518-3767-0",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (70518-3767-0) ",
"NDC11Code": "70518-3767-00",
"ProductNDC": "70518-3767",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230616",
"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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "0054-0088-13",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0054-0088-13) ",
"NDC11Code": "00054-0088-13",
"ProductNDC": "0054-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Acetate",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077728",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "667",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080228",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).",
"Description": "Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Each white opaque/blue opaque capsule contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Calcium Acetate Capsules, USP are administered orally for the control of hyperphosphatemia in end-stage renal failure."
},
{
"NDCCode": "0054-0088-26",
"PackageDescription": "200 CAPSULE in 1 BOTTLE (0054-0088-26) ",
"NDC11Code": "00054-0088-26",
"ProductNDC": "0054-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Acetate",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077728",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "667",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080228",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).",
"Description": "Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Each white opaque/blue opaque capsule contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Calcium Acetate Capsules, USP are administered orally for the control of hyperphosphatemia in end-stage renal failure."
},
{
"NDCCode": "0074-2108-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2108-03",
"ProductNDC": "0074-2108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-2282-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2282-03",
"ProductNDC": "0074-2282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-2440-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2440-03",
"ProductNDC": "0074-2440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3346-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3346-03",
"ProductNDC": "0074-3346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3346-55",
"PackageDescription": "1 KIT in 1 CELLO PACK (0074-3346-55) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3346-55",
"ProductNDC": "0074-3346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260315",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3473-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3473-03",
"ProductNDC": "0074-3473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>30142-169-53</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-169-53) > 25 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0169-53</NDC11Code>
<ProductNDC>30142-169</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209107</ApplicationNumber>
<LabelerName>KROGER COMPANY</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-169-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-169-12) > 40 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0169-12</NDC11Code>
<ProductNDC>30142-169</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride (allergy)</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209107</ApplicationNumber>
<LabelerName>KROGER COMPANY</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-142-53</NDCCode>
<PackageDescription>150 g in 1 CAN (30142-142-53) </PackageDescription>
<NDC11Code>30142-0142-53</NDC11Code>
<ProductNDC>30142-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole Nitrate</ProprietaryName>
<NonProprietaryName>Antifungal Liquid Continuous Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Kroger Co.</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/150g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris). relieves symptoms of athlete's foot, including itching burning and cracking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-147-53</NDCCode>
<PackageDescription>150 g in 1 CAN (30142-147-53) </PackageDescription>
<NDC11Code>30142-0147-53</NDC11Code>
<ProductNDC>30142-147</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tolnaftate</ProprietaryName>
<NonProprietaryName>Antifungal Spray Liquid</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Kroger Co.</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>g/150g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot (tinea pedis) and ringworm (tinea corporis). if used daily, can prevent recurrence of athlete's foot. relieves sypmtoms of athlete's foot, including itching, burning and cracking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-425-53</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (30142-425-53) > 6 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0425-53</NDC11Code>
<ProductNDC>30142-425</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexo Fenadine</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>30142-555-53</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (30142-555-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0555-53</NDC11Code>
<ProductNDC>30142-555</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-581-53</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (30142-581-53) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0581-53</NDC11Code>
<ProductNDC>30142-581</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal Anti Gas</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride, Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209837</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-935-53</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (30142-935-53) > 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0935-53</NDC11Code>
<ProductNDC>30142-935</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Sinus</ProprietaryName>
<ProprietaryNameSuffix>Congestion And Pain</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>30142-998-53</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (30142-998-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0998-53</NDC11Code>
<ProductNDC>30142-998</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>27241-167-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-167-01) </PackageDescription>
<NDC11Code>27241-0167-01</NDC11Code>
<ProductNDC>27241-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-167-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-167-10) </PackageDescription>
<NDC11Code>27241-0167-10</NDC11Code>
<ProductNDC>27241-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-168-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-168-01) </PackageDescription>
<NDC11Code>27241-0168-01</NDC11Code>
<ProductNDC>27241-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-168-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-168-10) </PackageDescription>
<NDC11Code>27241-0168-10</NDC11Code>
<ProductNDC>27241-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-169-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-169-01) </PackageDescription>
<NDC11Code>27241-0169-01</NDC11Code>
<ProductNDC>27241-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-169-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-169-10) </PackageDescription>
<NDC11Code>27241-0169-10</NDC11Code>
<ProductNDC>27241-169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-170-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-170-01) </PackageDescription>
<NDC11Code>27241-0170-01</NDC11Code>
<ProductNDC>27241-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-170-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-170-10) </PackageDescription>
<NDC11Code>27241-0170-10</NDC11Code>
<ProductNDC>27241-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-171-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-171-01) </PackageDescription>
<NDC11Code>27241-0171-01</NDC11Code>
<ProductNDC>27241-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-171-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-171-10) </PackageDescription>
<NDC11Code>27241-0171-10</NDC11Code>
<ProductNDC>27241-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200220</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>67046-0394-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (67046-0394-3) </PackageDescription>
<NDC11Code>67046-0394-03</NDC11Code>
<ProductNDC>67046-0394</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260616</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>70518-3594-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (70518-3594-1) </PackageDescription>
<NDC11Code>70518-3594-01</NDC11Code>
<ProductNDC>70518-3594</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250207</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>70518-3767-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (70518-3767-0) </PackageDescription>
<NDC11Code>70518-3767-00</NDC11Code>
<ProductNDC>70518-3767</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230616</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, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol 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, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0054-0088-13</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0054-0088-13) </PackageDescription>
<NDC11Code>00054-0088-13</NDC11Code>
<ProductNDC>0054-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Acetate</ProprietaryName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077728</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>667</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).</IndicationAndUsage>
<Description>Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Each white opaque/blue opaque capsule contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Calcium Acetate Capsules, USP are administered orally for the control of hyperphosphatemia in end-stage renal failure.</Description>
</NDC>
<NDC>
<NDCCode>0054-0088-26</NDCCode>
<PackageDescription>200 CAPSULE in 1 BOTTLE (0054-0088-26) </PackageDescription>
<NDC11Code>00054-0088-26</NDC11Code>
<ProductNDC>0054-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Acetate</ProprietaryName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077728</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>667</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).</IndicationAndUsage>
<Description>Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is. Each white opaque/blue opaque capsule contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Calcium Acetate Capsules, USP are administered orally for the control of hyperphosphatemia in end-stage renal failure.</Description>
</NDC>
<NDC>
<NDCCode>0074-2108-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2108-03</NDC11Code>
<ProductNDC>0074-2108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-2282-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2282-03</NDC11Code>
<ProductNDC>0074-2282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
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<NDC>
<NDCCode>0074-2440-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2440-03</NDC11Code>
<ProductNDC>0074-2440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3346-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3346-03</NDC11Code>
<ProductNDC>0074-3346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3346-55</NDCCode>
<PackageDescription>1 KIT in 1 CELLO PACK (0074-3346-55) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3346-55</NDC11Code>
<ProductNDC>0074-3346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3473-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3473-03</NDC11Code>
<ProductNDC>0074-3473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
</NDCList>