FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
69584-885
11-digit product format
695840885
Labeler code
69584
Product ID
69584-885_21124c29-b0a7-4729-90f8-0e971d265b61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA072193
Marketing category
ANDA
Marketing start
2023-03-01
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A072193-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1989-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072193-001AB

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 22:54:322026-06A072193-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1989-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A072193-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEOxford Pharmaceuticals, LLC283c8236-9776-44cb-b7b2-1024689de7362026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072193
application number: ANDA072193
ndc (product): 69584-885

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6E8ZO8LRNMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856373Internal RxNorm lookup
856377Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283c8236-9776-44cb-b7b2-1024689de736Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69584-885-10Trazodone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
69584-885-50Trazodone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
69584-885-90Trazodone Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-885TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [OXFORD PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20230301_283c8236-9776-44cb-b7b2-1024689de736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN283c8236-9776-44cb-b7b2-1024689de7361
856377traZODone HCl 50 MG Oral TabletPSN283c8236-9776-44cb-b7b2-1024689de7361
856373trazodone hydrochloride 100 MG Oral TabletSCD283c8236-9776-44cb-b7b2-1024689de7361
856377trazodone hydrochloride 50 MG Oral TabletSCD283c8236-9776-44cb-b7b2-1024689de7361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69584-885-096958408850990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-09)2026-07-100Current
69584-885-1069584088510100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-10) 2023-03-01NoNoCurrent
69584-885-5069584088550500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-50) 2023-03-01NoNoCurrent
69584-885-90695840885901000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69584-885-90) 2023-03-01NoNoCurrent