Home NDC 10544-533 Trazodone Hydrochloride
Product NDC 10544-533
11-digit product format 105440533
Labeler code 10544
Product ID 10544-533_004ddf52-9e87-44a4-97e2-3c3293f7cf8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA071525
Marketing category ANDA
Marketing start 2010-03-03
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-533-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-533-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-533-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-533-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-533-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-533-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-533-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-533-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-533-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-533-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-533-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-533-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-533-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-533-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-533-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-533-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-533-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-533-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-533-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-533-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-533-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-533-30 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 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…2022-10-28 04:53 UTC 2022-10 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 10544-533-30 Trazodone Hydrochloride 30 in 1 BOTTLE TABLET 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRAZODONE HYDROCHLORIDE ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 TRAZODONE ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-533 TRAZODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20110609_af82c9b0-1c3a-407a-aa5d-f15b9217b5c6.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 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 PD-Rx Pharmaceuticals, Inc. 9b022ae9-dd52-43ae-804b-ddf8e7cfd530 2025-10-01 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 Status 10544-533-30 10544053330 30 in 1 BOTTLE Historical