FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
42291-834
Requested package NDC
42291-834-90
11-digit product format
422910834
Labeler code
42291
Product ID
42291-834_de1d7168-0361-2ea8-e053-2995a90a2e8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA071524
Marketing category
ANDA
Marketing start
2014-02-06
Marketing end
2022-06-30
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 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 packagepackage42291-83442291-834-90DDiscontinued 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
A071524-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071524-001AB

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 22:54:322026-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071524-001AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsdf17cec9-ad5e-4e57-8572-c927c9b955e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.7bba99e5-4096-4fcb-8591-dc4a9bfe975e2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b617348c-cb19-45df-b313-4ea6af6f1dda2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCe07d7ee3-776d-1fa3-e053-2a95a90a70192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-834-10EA - Each42291-8340db8d0e5-1eeb-45c4-a014-a6a0a9fcf07e12014-05-02
42291-834-90EA - Each42291-834a28640b1-5516-42fd-bbee-544cd3ea6bfc12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJTRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE) TABLET [AVKARE, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-834-904229108349090 TABLET in 1 BOTTLE (42291-834-90) 90 tablet2016-06-270000-00-00NoNoCurrent