FDA.reportPublic FDA data

Trazodone Hydrochloride

Product NDC
70010-231
Requested package NDC
70010-231-05
11-digit product format
700100231
Labeler code
70010
Product ID
70010-231_5096700d-3b93-70a3-e063-6294a90ad1d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA218988
Marketing category
ANDA
Marketing start
2024-08-09
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A218988-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2024-08-08
A218988-002TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2024-08-08
A218988-003TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2024-08-08
A218988-004TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2024-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218988-001AB
A218988-002AB
A218988-003AB
A218988-004AB

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 22:54:322026-06A218988-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06A218988-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06A218988-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06A218988-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2024-08-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218988-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218988-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A218988-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A218988-004AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEGranules Pharmaceuticals Inc.5bc5f266-6c0e-4b9a-b6e0-ea694928b9482026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218988
application number: ANDA218988
ndc (package): 70010-231-05
ndc (product): 70010-231
ndc11 (package): 70010023105
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEUnit Dose Solutions, Inc.562fa890-0a39-9361-e063-6294a90a1bb52026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218988
application number: ANDA218988
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEGolden State Medical Supply, Inc.51012256-b249-ccbb-e063-6394a90af4fa2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218988
application number: ANDA218988
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC31356804-951b-68c7-e063-6294a90a64102025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218988
application number: ANDA218988
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC2c7dca0c-8313-7d85-e063-6294a90aca612025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218988
application number: ANDA218988

Additional Listing Data#

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

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
5bc5f266-6c0e-4b9a-b6e0-ea694928b948Available 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
70010-231-01Trazodone Hydrochloride100 in 1 BOTTLETABLET1004
70010-231-03Trazodone Hydrochloride30 in 1 BOTTLETABLET304
70010-231-05Trazodone Hydrochloride500 in 1 BOTTLETABLET5004
70010-231-10Trazodone Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-231-01EA - Each70010-2311b6e1422-cde2-4bc9-a20f-e0d6266e400812024-09-09
70010-231-05EA - Each70010-231028c9590-9774-49eb-a441-8d5c29304fb812024-09-09
70010-231-10EA - Each70010-231a228ec12-f4aa-4870-8d02-09bbc90dce3d12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-231TRAZODONE HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250326_5bc5f266-6c0e-4b9a-b6e0-ea694928b948.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856373traZODone HCl 100 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856364traZODone HCl 150 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856369traZODone HCl 300 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856377traZODone HCl 50 MG Oral TabletPSN5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856373trazodone hydrochloride 100 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856364trazodone hydrochloride 150 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856369trazodone hydrochloride 300 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856377trazodone hydrochloride 50 MG Oral TabletSCD5bc5f266-6c0e-4b9a-b6e0-ea694928b9484
856377traZODone HCl 50 MG Oral TabletPSN2c7dca0c-8313-7d85-e063-6294a90aca612
856377trazodone hydrochloride 50 MG Oral TabletSCD2c7dca0c-8313-7d85-e063-6294a90aca612
856373traZODone HCl 100 MG Oral TabletPSN51012256-b249-ccbb-e063-6394a90af4fa1
856377traZODone HCl 50 MG Oral TabletPSN51012256-b249-ccbb-e063-6394a90af4fa1
856373trazodone hydrochloride 100 MG Oral TabletSCD51012256-b249-ccbb-e063-6394a90af4fa1
856377trazodone hydrochloride 50 MG Oral TabletSCD51012256-b249-ccbb-e063-6394a90af4fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-231-0570010023105500 TABLET in 1 BOTTLE (70010-231-05) 500 tablet2024-08-09NoNoCurrent