Home NDC 71610-513 Trazodone Hydrochloride
Product NDC 71610-513
11-digit product format 716100513
Labeler code 71610
Product ID 71610-513_7309a57d-a286-4cde-82fe-5a84f5823572
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA071196
Marketing category ANDA
Marketing start 2008-11-17
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071196-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 A071196-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 A071196-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE REMEDYREPACK INC. dc1f347e-1acb-4c06-b36e-f15fecb7ac93 2026-04-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Apotex Corp 71961ab1-951d-1493-f76c-2ff25cca2a85 2026-03-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 5d22a06c-9cb8-4b49-8d67-769d181ad70c 2021-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 ndc (product): 71610-513 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 9c4da6ad-d4d1-4e8c-918d-8ac48512a93f 2020-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196
Additional Listing Data#
Finished product Yes
Brand name base Trazodone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6E8ZO8LRNM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856373 Internal RxNorm lookup 856377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-513-30 Trazodone Hydrochloride 30 in 1 BOTTLE TABLET 30 1 71610-513-60 Trazodone Hydrochloride 90 in 1 BOTTLE TABLET 90 1 71610-513-80 Trazodone Hydrochloride 180 in 1 BOTTLE TABLET 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-513 TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 3 package rows 20210313_5d22a06c-9cb8-4b49-8d67-769d181ad70c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71610-513-30 71610051330 30 TABLET in 1 BOTTLE (71610-513-30) 30 tablet 2021-01-06 0000-00-00 No No Current 71610-513-60 71610051360 90 TABLET in 1 BOTTLE (71610-513-60) 90 tablet 2021-01-04 0000-00-00 No No Current 71610-513-80 71610051380 180 TABLET in 1 BOTTLE (71610-513-80) 180 tablet 2021-02-12 0000-00-00 No No Current