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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

Granules Pharmaceuticals Inc.

DUNS: 079825711

Effective Date

March 24, 2025

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Trazodone(50 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Granules India Limited

Labeler

Granules Pharmaceuticals Inc.

DUNS Number

918609236

Products4

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

70010-231

Application Number

ANDA218988

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 24, 2025

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TrazodoneActive

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

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4DClass: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code

70010-234

Application Number

ANDA218988

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 24, 2025

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4DClass: IACT

TrazodoneActive

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

Trazodone Hydrochloride

Product Details

NDC Product Code

70010-232

Application Number

ANDA218988

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 24, 2025

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4DClass: IACT

TrazodoneActive

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

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code

70010-233

Application Number

ANDA218988

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 24, 2025

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SODIUM STARCH GLYCOLATE TYPE AInactive

Code: H8AV0SQX4DClass: IACT

TrazodoneActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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