Trazodone Hydrochloride

Product NDC
63629-1513
11-digit product format
636291513
Labeler code
63629
Product ID
63629-1513_bac3411a-00df-4d1e-8059-3247c32614df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA072192
Marketing category
ANDA
Marketing start
2010-05-30
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1513DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-0DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-1DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-2DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-3DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-4DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-5DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-6DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-7DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-8DDiscontinued by firm2026-07-31
excluded packagepackage63629-151363629-1513-9DDiscontinued 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
A072192-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1989-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072192-001AB

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 22:54:322026-06A072192-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1989-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A072192-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEOxford Pharmaceuticals, LLC283c8236-9776-44cb-b7b2-1024689de7362026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072192
application number: ANDA072192

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1513-1EA - Each63629-15139e6416c7-d8c9-4a90-813b-3a8b203834d912012-07-24
63629-1513-2EA - Each63629-151333358820-ec23-4b47-96ae-a547f027943712012-07-24
63629-1513-3EA - Each63629-151322fd6a77-5739-45f7-bdaf-6c9116877e3512012-07-24
63629-1513-4EA - Each63629-1513392c8905-455e-469e-9b3f-33863cb895f312012-07-24
63629-1513-5EA - Each63629-1513cb6a3bde-71a9-4691-9ba9-02eaa989d6f412012-07-24