FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
68071-3099
11-digit product format
680713099
Labeler code
68071
Product ID
68071-3099_4a69b54d-a8c3-52b1-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA071258
Marketing category
ANDA
Marketing start
2008-11-17
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
2020-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-3099DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-2DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-3DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-4DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-5DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-6DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-8DDiscontinued by firm2026-07-31
excluded packagepackage68071-309968071-3099-9DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071258-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071258-001AB

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 22:54:322026-06A071258-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071258-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEApotex Corp71961ab1-951d-1493-f76c-2ff25cca2a852026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071258
application number: ANDA071258
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5d22a06c-9cb8-4b49-8d67-769d181ad70c2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071258
application number: ANDA071258