FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
55289-060
11-digit product format
552890060
Labeler code
55289
Product ID
55289-060_a36d7352-c543-0ab4-e053-2a95a90a21d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA071525
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
2021-10-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-060DDiscontinued by firm2026-07-31
excluded packagepackage55289-06055289-060-14DDiscontinued by firm2026-07-31
excluded packagepackage55289-06055289-060-30DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071525-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071525-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071525-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREa382ac4d-9ab9-796a-e053-2a95a90a2c262026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9b022ae9-dd52-43ae-804b-ddf8e7cfd5302025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-060-14EA - Each55289-060fda4e359-f825-47e2-8d1f-1ba152bd20e012012-07-24
55289-060-30EA - Each55289-0609a9d50d5-a091-472a-b69a-5a5c3546c8a612014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-060-145528900601414 TABLET in 1 BOTTLE, PLASTIC (55289-060-14) 14 tablet2014-06-112021-10-31NoNoCurrent
55289-060-305528900603030 TABLET in 1 BOTTLE, PLASTIC (55289-060-30) 30 tablet2014-06-112021-10-31NoNoCurrent