FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
16729-299
11-digit product format
167290299
Labeler code
16729
Product ID
16729-299_4629674c-30f5-3709-e063-6394a90a3dc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA206923
Marketing category
ANDA
Marketing start
2018-10-05
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206923-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08
A206923-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08
A206923-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08
A206923-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A206923-001AB
A206923-002AB
A206923-003AB
A206923-004AB

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 22:54:322026-06A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08a50c72e98297…
2026-08-01 22:54:322026-06A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206923-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206923-004AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepack5605e909-dc75-4578-94c6-41bb96ba3e2a2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack78c3188c-d42f-4d3d-aa42-3c146dfe08ee2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAccord Healthcare, Inc.ed3039d8-3d27-4b71-a4b0-812943c9457f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
ndc (product): 16729-299
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPa90caa68-b28e-425f-b77c-7b566ac17dc22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923

Additional Listing Data#

Finished product
Yes
Brand name base
Trazodone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAZODONE HYDROCHLORIDE50 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856364Internal RxNorm lookup
856369Internal RxNorm lookup
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
ed3039d8-3d27-4b71-a4b0-812943c9457fAvailable 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
16729-299-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10012
16729-299-16Trazodone Hydrochloride500 in 1 BOTTLETABLET50012
16729-299-17Trazodone Hydrochloride1000 in 1 BOTTLETABLET100012
16729-299-43Trazodone Hydrochloride10 in 1 CARTONTABLET1012
16729-299-44Trazodone Hydrochloride10 in 1 BLISTER PACKTABLET1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-299-01EA - Each16729-29924e54195-5c0e-4394-85fe-470dd0bedfb112018-11-06
16729-299-17EA - Each16729-299fe36602d-59f5-4965-b381-a88256d3ad3512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-299TRAZODONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 5 package rows20240221_ed3039d8-3d27-4b71-a4b0-812943c9457f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN78c3188c-d42f-4d3d-aa42-3c146dfe08ee105
856377trazodone hydrochloride 50 MG Oral TabletSCD78c3188c-d42f-4d3d-aa42-3c146dfe08ee105
856373traZODone HCl 100 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856364traZODone HCl 150 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856369traZODone HCl 300 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856377traZODone HCl 50 MG Oral TabletPSNed3039d8-3d27-4b71-a4b0-812943c9457f12
856373trazodone hydrochloride 100 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856364trazodone hydrochloride 150 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856369trazodone hydrochloride 300 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856377trazodone hydrochloride 50 MG Oral TabletSCDed3039d8-3d27-4b71-a4b0-812943c9457f12
856377traZODone HCl 50 MG Oral TabletPSNb9489fca-1b10-8814-e053-2a95a90acbeb5
856377trazodone hydrochloride 50 MG Oral TabletSCDb9489fca-1b10-8814-e053-2a95a90acbeb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-299-0116729029901100 TABLET in 1 BOTTLE (16729-299-01) 100 tablet2018-10-050000-00-00NoNoCurrent
16729-299-1616729029916500 in 1 BOTTLEHistorical
16729-299-17167290299171000 TABLET in 1 BOTTLE (16729-299-17) 1000 tablet2018-10-250000-00-00NoNoCurrent
16729-299-431672902994310 in 1 CARTONHistorical
16729-299-441672902994410 in 1 BLISTER PACKHistorical