FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
42291-835
Requested package NDC
42291-835-90
11-digit product format
422910835
Labeler code
42291
Product ID
42291-835_c3df170e-8b75-5a43-e053-2995a90a71ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA071525
Marketing category
ANDA
Marketing start
2014-02-06
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-83542291-835-90DDiscontinued 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
A071525-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071525-001AB

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 22:54:322026-06A071525-001TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1988-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071525-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREa382ac4d-9ab9-796a-e053-2a95a90a2c262026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9b022ae9-dd52-43ae-804b-ddf8e7cfd5302025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071525
application number: ANDA071525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-835-50EA - Each42291-8350fb42dd5-f113-4592-92f2-aa555fd71e8a12014-05-02
42291-835-90EA - Each42291-83554e16c07-fd15-4e99-8214-06c4e4aeae1812016-09-02

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
42291-835-904229108359090 TABLET in 1 BOTTLE (42291-835-90) 90 tablet2016-06-270000-00-00NoNoCurrent