FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
50090-2393
11-digit product format
500902393
Labeler code
50090
Product ID
50090-2393_b356d651-5fcf-4d70-8f73-b2913093998c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA073137
Marketing category
ANDA
Marketing start
1993-03-24
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2393DDiscontinued by firm2026-07-31
excluded packagepackage50090-239350090-2393-0DDiscontinued by firm2026-07-31
excluded packagepackage50090-239350090-2393-1DDiscontinued by firm2026-07-31
excluded packagepackage50090-239350090-2393-6DDiscontinued by firm2026-07-31
excluded packagepackage50090-239350090-2393-8DDiscontinued by firm2026-07-31
excluded packagepackage50090-239350090-2393-9DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073137-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24
A073137-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24
A073137-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A073137-001AB
A073137-002AB
A073137-003AB

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 22:54:322026-06A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073137-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-003AB1a50c72e98297…

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 HYDROCHLORIDECoupler LLC55f18806-6c23-783b-e063-6294a90acc462026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC4c4ca53e-9201-298c-e063-6294a90a72c62026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.fa7afa93-b98c-4dc7-bbb8-ab6a058427b92025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.f291b905-a739-5e43-e053-2995a90ac40c2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2393-0EA - Each50090-2393ac8d0558-672c-40dc-b9d3-b4137ffd406a12019-02-13
50090-2393-1EA - Each50090-2393ee369a81-104a-459a-90f6-d19b471657e912019-02-13
50090-2393-6EA - Each50090-23939bb47524-2902-451c-9087-e412cc0d1c7d12019-02-13
50090-2393-8EA - Each50090-23930a7c29dc-8660-443b-858b-2bde86fb8ecf12019-02-13
50090-2393-9EA - Each50090-2393ca6ab9e1-dcaf-4398-b69e-dd2e993f466712019-02-13