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Trazodone Hydrochloride

TRAZODONE HYDROCHLORIDE TABLETS, USP

Approved
Approval ID

28080f0c-0b6c-4d95-8a53-6474bb876b0e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 9, 2010

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 2

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

Trazodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-741
Application NumberANDA071524
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Trazodone Hydrochoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-740
Application NumberANDA071523
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochoride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Trazodone Hydrochloride - FDA Drug Approval Details