FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
57664-053
11-digit product format
576640053
Labeler code
57664
Product ID
57664-053_323e3d63-4d8d-7088-e063-6294a90abb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA073137
Marketing category
ANDA
Marketing start
2022-10-03
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073137-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24
A073137-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24
A073137-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A073137-001AB
A073137-002AB
A073137-003AB

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 22:54:322026-06A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24a50c72e98297…
2026-08-01 22:54:322026-06A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073137-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A073137-003AB1a50c72e98297…

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 HYDROCHLORIDECoupler LLC55f18806-6c23-783b-e063-6294a90acc462026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC4c4ca53e-9201-298c-e063-6294a90a72c62026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.fa7afa93-b98c-4dc7-bbb8-ab6a058427b92025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.f291b905-a739-5e43-e053-2995a90ac40c2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073137
application number: ANDA073137
ndc (product): 57664-053

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856364Internal 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
f291b905-a739-5e43-e053-2995a90ac40cAvailable 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
57664-053-72Trazodone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1004
57664-053-74Trazodone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-053-72EA - Each57664-05331afe7c8-d1f8-4003-be23-1318641e6c3d12024-07-12
57664-053-74EA - Each57664-05348dc0da3-d099-453e-9934-df3b821ed03312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-053TRAZODONE HYDROCHLORIDE TABLET, FILM COATED TRAZODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, 2 package rows20250412_f291b905-a739-5e43-e053-2995a90ac40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSNf291b905-a739-5e43-e053-2995a90ac40c4
856364traZODone HCl 150 MG Oral TabletPSNf291b905-a739-5e43-e053-2995a90ac40c4
856377traZODone HCl 50 MG Oral TabletPSNf291b905-a739-5e43-e053-2995a90ac40c4
856373trazodone hydrochloride 100 MG Oral TabletSCDf291b905-a739-5e43-e053-2995a90ac40c4
856364trazodone hydrochloride 150 MG Oral TabletSCDf291b905-a739-5e43-e053-2995a90ac40c4
856377trazodone hydrochloride 50 MG Oral TabletSCDf291b905-a739-5e43-e053-2995a90ac40c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57664-053-7257664005372100 TABLET in 1 BOTTLE, PLASTIC (57664-053-72) 100 tablet2022-10-03NoNoCurrent
57664-053-7457664005374500 TABLET in 1 BOTTLE, PLASTIC (57664-053-74) 500 tablet2022-10-03NoNoCurrent