Home NDC 67046-1662 Trazodone Hydrochloride
Product NDC 67046-1662
11-digit product format 670461662
Labeler code 67046
Product ID 67046-1662_4c4c97d0-fe68-18ea-e063-6294a90abaf9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Coupler LLC
Application ANDA073137
Marketing category ANDA
Marketing start 2026-03-05
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A073137-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 A073137-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 A073137-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22
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.
Product history page 1 of 4 · 126 observed 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 2026-08-18 06:07:40 2026-07 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073137-002 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1993-03-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073137-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1995-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073137-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1993-03-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trazodone Hydrochloride
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856373 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 67046-1662-3 Trazodone Hydrochloride 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 Coupler LLC 55f18806-6c23-783b-e063-6294a90acc46 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073137 application number: ANDA073137 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Coupler LLC 4c4ca53e-9201-298c-e063-6294a90a72c6 2026-03-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073137 application number: ANDA073137 ndc (product): 67046-1662 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE REMEDYREPACK INC. fa7afa93-b98c-4dc7-bbb8-ab6a058427b9 2025-07-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073137 application number: ANDA073137 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. f291b905-a739-5e43-e053-2995a90ac40c 2025-04-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073137 application number: ANDA073137
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67046-1662-3 67046166203 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1662-3) 2026-03-05 No No Current