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FDA Approval

Trazodone Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 845263701

Effective Date

May 25, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Trazodone(150 mg in 1 1)

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trazodone Hydrochloride

Product Details

NDC Product Code

60505-4089

Application Number

ANDA071196

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

TrazodoneActive

Code: 6E8ZO8LRNMClass: ACTIBQuantity: 150 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code

60505-2654

Application Number

ANDA071196

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

TrazodoneActive

Code: 6E8ZO8LRNMClass: ACTIBQuantity: 100 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code

60505-2659

Application Number

ANDA071196

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

TrazodoneActive

Code: 6E8ZO8LRNMClass: ACTIBQuantity: 300 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code

60505-2653

Application Number

ANDA071258

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

TrazodoneActive

Code: 6E8ZO8LRNMClass: ACTIBQuantity: 50 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code

60505-2655

Application Number

ANDA071196

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 25, 2023

Ingredients

TrazodoneActive

Code: 6E8ZO8LRNMClass: ACTIBQuantity: 150 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS and BEHAVIORS

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