Home NDC 57664-014 Trazodone Hydrochloride
Product NDC 57664-014
11-digit product format 576640014
Labeler code 57664
Product ID 57664-014_323e3d63-4d8d-7088-e063-6294a90abb0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA073137
Marketing category ANDA
Marketing start 2022-10-03
Substance TRAZODONE HYDROCHLORIDE
Active strength 50 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 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 50 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856364 Internal RxNorm lookup 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 57664-014-72 Trazodone Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 4 57664-014-74 Trazodone Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 4 57664-014-75 Trazodone Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-014 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED TRAZODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Current NDC, 3 package rows 20250412_f291b905-a739-5e43-e053-2995a90ac40c.zip
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 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 ndc (product): 57664-014
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 57664-014-72 57664001472 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72) 2022-10-03 No No Current 57664-014-74 57664001474 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74) 2022-10-03 No No Current 57664-014-75 57664001475 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-75) 2022-10-03 No No Current