Home NDC 50090-0463 Trazodone Hydrochloride
Product NDC 50090-0463
11-digit product format 500900463
Labeler code 50090
Product ID 50090-0463_ef76c5ec-1385-4a2a-bea2-811998f57ced
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA071525
Marketing category ANDA
Marketing start 1990-09-30
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A071525-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071525-001 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.
Product history page 1 of 2 · 44 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 2026-10-15 13:18:30 2026-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0463-2 Trazodone Hydrochloride 30 in 1 BOTTLE TABLET 30 7 50090-0463-4 Trazodone Hydrochloride 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0463 TRAZODONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 7 Legacy NDC, 2 package rows 20210219_29c443fc-8ef6-4778-8d6a-ad14181ef8de.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE NCS HealthCare of KY, LLC dba Vangard Labs 310c4b81-d2cf-4014-873d-e71d036105de 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE AvKARE a382ac4d-9ab9-796a-e053-2a95a90a2c26 2026-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 4006d439-e2de-4590-82e9-fc9d56e3ec1b 2025-07-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525
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 50090-0463-2 50090046302 30 TABLET in 1 BOTTLE (50090-0463-2) 30 tablet 2016-06-29 0000-00-00 No No Current 50090-0463-4 50090046304 90 TABLET in 1 BOTTLE (50090-0463-4) 90 tablet 2019-02-08 0000-00-00 No No Current