Home NDC 0603-6161 Trazodone Hydrochloride
Product NDC 0603-6161
11-digit product format 006036161
Labeler code 0603
Product ID 0603-6161_33d705b2-795f-4fb8-96f2-96d48e6de326
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Par Pharmaceutical
Application ANDA072193
Marketing category ANDA
Marketing start 2010-05-30
Marketing end 2021-06-30
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072193-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072193-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A072193-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRAZODONE HYDROCHLORIDE ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 TRAZODONE ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 POVIDONES INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 TRAZODONE HYDROCHLORIDE ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Trazodone Hydrochloride ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 trazodone ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 TRAZODONE ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 hypromellose INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 polydextrose INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 povidone INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0603-6161-21 00603616121 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6161-21) 2010-05-30 2021-06-30 No No Current 0603-6161-28 00603616128 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6161-28) 2010-05-30 2021-05-31 No No Current