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Trazodone Hydrochloride

TRAZODONE HYDROCHLORIDE TABLETS, USP

Approved
Approval ID

4e0ce52d-2639-42a2-a4e4-7854421fa1b6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 11, 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 Code67046-742
Application NumberANDA072193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2009
FDA Product Classification

INGREDIENTS (10)

magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Trazodone HydrochlorideActive
Quantity: 100 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT

Trazodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-739
Application NumberANDA072192
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2009
FDA Product Classification

INGREDIENTS (10)

Trazodone HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT

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Trazodone Hydrochloride - FDA Drug Approval Details