FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
21695-133
11-digit product format
216950133
Labeler code
21695
Product ID
21695-133_370453cb-7636-43f2-93f0-e8714884fab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA071523
Marketing category
ANDA
Marketing start
1987-12-11
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-133IInactivated by FDA2026-07-31
excluded packagepackage21695-13321695-133-30IInactivated by FDA2026-07-31
excluded packagepackage21695-13321695-133-60IInactivated by FDA2026-07-31
excluded packagepackage21695-13321695-133-72IInactivated by FDA2026-07-31
excluded packagepackage21695-13321695-133-90IInactivated 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
A071523-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / 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
A071523-001AB

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 22:54:322026-06A071523-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1987-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A071523-001AB1a50c72e98297…

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 HYDROCHLORIDEUnit Dose Solutions, Inc.562fdfb9-c060-63bc-e063-6294a90ad8402026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.38e9820a-6edc-4bf5-b5e4-034b9e48b5832026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs310c4b81-d2cf-4014-873d-e71d036105de2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCf2f2290f-b53c-3b38-e053-2995a90a157d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPf6c3fb84-5b68-4675-a853-fe49bfbf3f9f2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071523
application number: ANDA071523

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
21695-133-302019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP
21695-133-602019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP
21695-133-722019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP
21695-133-902019-09-24C16284748780-1934fe258-4a07-48b1-e053-8cdaa90a720aTRAZODONE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-133-30Trazodone Hydrochloride30 in 1 BOTTLETABLET302
21695-133-60Trazodone Hydrochloride60 in 1 BOTTLETABLET602
21695-133-72Trazodone Hydrochloride120 in 1 BOTTLETABLET1202
21695-133-90Trazodone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-133-30EA - Each21695-133411c87de-c36d-4ad6-8951-05cda2b4d3b812012-07-24
21695-133-60EA - Each21695-1339be7b03c-e473-4be2-87cd-b0032f3aa34112012-07-24
21695-133-72EA - Each21695-1331c96eae1-420c-47ae-9df5-38b83610fe1812012-07-24
21695-133-90EA - Each21695-13354713f2c-9fff-4da5-bebe-76792aaaa66d12012-07-24

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
21695-133TRAZODONE HYDROCHLORIDE (TRAZODONE) TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 4 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
21695-133-302169501333030 in 1 BOTTLEHistorical
21695-133-602169501336060 in 1 BOTTLEHistorical
21695-133-7221695013372120 in 1 BOTTLEHistorical
21695-133-902169501339090 in 1 BOTTLEHistorical