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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A071525-001 AB 1 a50c72e98297…
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 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 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
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