FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
16729-301
11-digit product format
167290301
Labeler code
16729
Product ID
16729-301_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
2018-10-17
Substance
TRAZODONE HYDROCHLORIDE
Active strength
150 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): 16729-301
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 HYDROCHLORIDE150 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
16729-301-01Trazodone Hydrochloride100 in 1 BOTTLETABLET10012
16729-301-16Trazodone Hydrochloride500 in 1 BOTTLETABLET50012
16729-301-17Trazodone Hydrochloride1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-301-01EA - Each16729-3018a50154f-b4d6-4170-a7c8-2b1db16bd4b112018-11-06
16729-301-16EA - Each16729-30135e86817-d359-4111-99de-1bfa7844001812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-301TRAZODONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 3 package rows20240221_ed3039d8-3d27-4b71-a4b0-812943c9457f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
856364traZODone HCl 150 MG Oral TabletPSN5605e909-dc75-4578-94c6-41bb96ba3e2a5
856364trazodone hydrochloride 150 MG Oral TabletSCD5605e909-dc75-4578-94c6-41bb96ba3e2a5
856364traZODone HCl 150 MG Oral TabletPSN86b4e9c0-d784-448b-8a52-9dd3ca92e2b31
856364trazodone hydrochloride 150 MG Oral TabletSCD86b4e9c0-d784-448b-8a52-9dd3ca92e2b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-301-0116729030101100 TABLET in 1 BOTTLE (16729-301-01) 100 tablet2018-10-170000-00-00NoNoCurrent
16729-301-1616729030116500 TABLET in 1 BOTTLE (16729-301-16) 500 tablet2018-10-230000-00-00NoNoCurrent
16729-301-17167290301171000 in 1 BOTTLEHistorical