Trazodone Hydrochloride

Product NDC
71335-1575
Requested package NDC
71335-1575-5
11-digit product format
713351575
Labeler code
71335
Product ID
71335-1575_ee5038da-8c02-4fd4-9034-e58f1f3d8e38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-157571335-1575-5DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-157571335-1575-5DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206923-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206923-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206923-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206923-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206923-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206923-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206923-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206923-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206923-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206923-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206923-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206923-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206923-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206923-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206923-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206923-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206923-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206923-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206923-004AB1d06236e962d9…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (package): 71335-1575-5
ndc (product): 71335-1575
ndc11 (package): 71335157505
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAccord Healthcare, Inc.ed3039d8-3d27-4b71-a4b0-812943c9457f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206923
application number: ANDA206923
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
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
78c3188c-d42f-4d3d-aa42-3c146dfe08eeAvailable 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
71335-1575-0Trazodone Hydrochloride14 in 1 BOTTLETABLET14105
71335-1575-1Trazodone Hydrochloride20 in 1 BOTTLETABLET20105
71335-1575-2Trazodone Hydrochloride30 in 1 BOTTLETABLET30105
71335-1575-3Trazodone Hydrochloride60 in 1 BOTTLETABLET60105
71335-1575-4Trazodone Hydrochloride90 in 1 BOTTLETABLET90105
71335-1575-5Trazodone Hydrochloride45 in 1 BOTTLETABLET45105
71335-1575-6Trazodone Hydrochloride100 in 1 BOTTLETABLET100105
71335-1575-7Trazodone Hydrochloride25 in 1 BOTTLETABLET25105
71335-1575-8Trazodone Hydrochloride120 in 1 BOTTLETABLET120105
71335-1575-9Trazodone Hydrochloride28 in 1 BOTTLETABLET28105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1575-2EA - Each71335-157546229f4c-e4ba-4e17-84f6-9270d650aeff12020-07-13
71335-1575-3EA - Each71335-15755394f850-ad00-4869-9834-1507994bf9c912023-12-05
71335-1575-4EA - Each71335-157521f4300f-7464-4184-bf37-cd35df2413e412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1575TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240830_78c3188c-d42f-4d3d-aa42-3c146dfe08ee.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1575-57133515750545 TABLET in 1 BOTTLE (71335-1575-5) 45 tablet2026-05-130000-00-00NoNoCurrent