Trazodone Hydrochloride

Product NDC
67296-1411
11-digit product format
672961411
Labeler code
67296
Product ID
67296-1411_b948b59c-6f26-cb9d-e053-2995a90af495
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA206923
Marketing category
ANDA
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1411IInactivated by FDA2026-08-17
excluded packagepackage67296-141167296-1411-3IInactivated by FDA2026-08-17

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1411-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1411-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1411-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1411-31332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206923-001TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB2017-09-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206923-002TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB2017-09-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206923-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB2017-09-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206923-004TRAZODONE HYDROCHLORIDE300MGTABLET / ORALAB2017-09-08caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206923-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206923-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206923-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206923-004AB1caaa826d4ba7…
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…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1411-3Trazodone Hydrochloride30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1411TRAZODONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20240808_b9489fca-1b10-8814-e053-2a95a90acbeb.zip

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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSNb9489fca-1b10-8814-e053-2a95a90acbeb5
856377trazodone hydrochloride 50 MG Oral TabletSCDb9489fca-1b10-8814-e053-2a95a90acbeb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1411-36729614110330 TABLET in 1 BOTTLE (67296-1411-3) 30 tablet2021-01-010000-00-00NoNoCurrent