FDA.reportPublic FDA data

TRAZODONE HYDROCHLORIDE

Product NDC
64980-673
11-digit product format
649800673
Labeler code
64980
Product ID
64980-673_ab9a16ff-7bca-4445-b6e5-5122e097995c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trazodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217740
Marketing category
ANDA
Marketing start
2025-01-29
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217740-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2024-08-27
A217740-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2024-08-27
A217740-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2024-08-27
A217740-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2024-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217740-001AB
A217740-002AB
A217740-003AB
A217740-004AB

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 22:54:322026-06A217740-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2024-08-27a50c72e98297…
2026-08-01 22:54:322026-06A217740-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2024-08-27a50c72e98297…
2026-08-01 22:54:322026-06A217740-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2024-08-27a50c72e98297…
2026-08-01 22:54:322026-06A217740-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2024-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217740-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217740-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217740-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A217740-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEREMEDYREPACK INC.1ec27d5d-1a88-428e-8de2-7418a3535a182026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217740
application number: ANDA217740
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDERising Pharma Holdings, Inc.ef26e4f0-f31f-4efa-9938-28c886cf3d1d2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217740
application number: ANDA217740
ndc (product): 64980-673

Additional Listing Data#

Finished product
Yes
Brand name base
TRAZODONE HYDROCHLORIDE
Listing expiration
2026-12-31

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 · 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
ef26e4f0-f31f-4efa-9938-28c886cf3d1dAvailable 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
64980-673-01TRAZODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1002
64980-673-10TRAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10002
64980-673-50TRAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-673-01EA - Each64980-673ee7fd90e-511d-4abe-9231-743dc176326512025-03-04
64980-673-10EA - Each64980-67338359268-2bb2-4475-8df7-bdf9e063a30412025-11-13
64980-673-50EA - Each64980-673882ac71f-83f3-4075-ac19-884919b8617212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-673TRAZODONE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 3 package rows20250515_ef26e4f0-f31f-4efa-9938-28c886cf3d1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856364traZODone HCl 150 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856369traZODone HCl 300 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856377traZODone HCl 50 MG Oral TabletPSNef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856373trazodone hydrochloride 100 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856364trazodone hydrochloride 150 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856369trazodone hydrochloride 300 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2
856377trazodone hydrochloride 50 MG Oral TabletSCDef26e4f0-f31f-4efa-9938-28c886cf3d1d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-673-0164980067301100 TABLET in 1 BOTTLE (64980-673-01) 100 tablet2025-01-29NoNoCurrent
64980-673-10649800673101000 TABLET in 1 BOTTLE (64980-673-10) 1000 tablet2025-04-11NoNoCurrent
64980-673-5064980067350500 TABLET in 1 BOTTLE (64980-673-50) 500 tablet2025-01-29NoNoCurrent