FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
21695-134
11-digit product format
216950134
Labeler code
21695
Product ID
21695-134_370453cb-7636-43f2-93f0-e8714884fab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA071524
Marketing category
ANDA
Marketing start
1987-12-11
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-134IInactivated by FDA2026-07-31
excluded packagepackage21695-13421695-134-30IInactivated by FDA2026-07-31
excluded packagepackage21695-13421695-134-60IInactivated by FDA2026-07-31
excluded packagepackage21695-13421695-134-90IInactivated by FDA2026-07-31

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525eProduct name120250730
b2f15d64-48ea-ba98-af5c-91f410667b31Product name520250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-134-302019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP
21695-134-602019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP
21695-134-902019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-134-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
21695-134-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
21695-134-90Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-134-30EA - Each21695-134dcc32c46-c530-437d-9ff2-025c0d2fbd1c12012-07-24
21695-134-60EA - Each21695-1341b1403af-c10e-4456-868e-8618abe7f8bb12012-07-24
21695-134-90EA - Each21695-1347cc2a8f4-5cd7-4040-abf4-8aac5eacae0612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]2
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-134TRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 3 package rows20111227_6f43cdc2-4f8e-4a5f-976a-d3aaac65593d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856364traZODone HCl 150 MG Oral TabletPSN6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856377traZODone HCl 50 MG Oral TabletPSN6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856373trazodone hydrochloride 100 MG Oral TabletSCD6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856364trazodone hydrochloride 150 MG Oral TabletSCD6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2
856377trazodone hydrochloride 50 MG Oral TabletSCD6f43cdc2-4f8e-4a5f-976a-d3aaac65593d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-134-302169501343030 in 1 BOTTLEHistorical
21695-134-602169501346060 in 1 BOTTLEHistorical
21695-134-902169501349090 in 1 BOTTLEHistorical