FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
63629-7287
Requested package NDC
63629-7287-3
11-digit product format
636297287
Labeler code
63629
Product ID
63629-7287_10a30879-f6e2-4030-95b8-0979c18c418a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071196
Marketing category
ANDA
Marketing start
1999-05-03
Marketing end
2022-10-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
300 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-728763629-7287-3DDiscontinued 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
A071196-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25
A071196-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26
A071196-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071196-001AB
A071196-002AB
A071196-003AB

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 22:54:322026-06A071196-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALABRS1987-03-25a50c72e98297…
2026-08-01 22:54:322026-06A071196-002TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1999-04-26a50c72e98297…
2026-08-01 22:54:322026-06A071196-003TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB1999-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071196-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A071196-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A071196-003AB1a50c72e98297…

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 HYDROCHLORIDEREMEDYREPACK INC.dc1f347e-1acb-4c06-b36e-f15fecb7ac932026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEApotex Corp71961ab1-951d-1493-f76c-2ff25cca2a852026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5d22a06c-9cb8-4b49-8d67-769d181ad70c2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9c4da6ad-d4d1-4e8c-918d-8ac48512a93f2020-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071196
application number: ANDA071196

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7287-12020-10-16C16284748780-19d75b9d1-0f9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
63629-7287-22020-10-16C16284748780-19d75b9d1-0f9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
63629-7287-32020-10-16C16284748780-19d75b9d1-0f9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
63629-7287-12020-01-31C16284748780-19d75b9d1-0f9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
63629-7287-22020-01-31C16284748780-19d75b9d1-0f9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
63629-7287-32020-01-31C16284748780-19d75b9d1-0f9c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7287-36362972870318 TABLET in 1 BOTTLE (63629-7287-3) 18 tablet2021-12-222022-10-31NoNoCurrent