Trazodone Hydrochloride

Product NDC
66116-357
11-digit product format
661160357
Labeler code
66116
Product ID
66116-357_9426f88d-2f3f-4dc9-ba17-f4bc0be91963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA073137
Marketing category
ANDA
Marketing start
1993-03-24
Marketing end
0000-00-00
Substance
TRAZODONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct66116-357IInactivated by FDA2026-08-17
excluded packagepackage66116-35766116-357-30IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66116-357-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66116-357-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66116-357-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66116-357-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66116-357-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66116-357-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66116-357-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66116-357-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66116-357-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66116-357-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66116-357-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66116-357-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66116-357-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66116-357-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66116-357-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66116-357-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66116-357-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66116-357-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66116-357-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66116-357-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66116-357-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66116-357-30110d247fa046…a55b01930146…

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

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073137-002TRAZODONE HYDROCHLORIDE50MGTABLET / ORALAB1993-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073137-003TRAZODONE HYDROCHLORIDE150MGTABLET / ORALAB1995-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073137-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1993-03-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A073137-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A073137-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A073137-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073137-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073137-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073137-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073137-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073137-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073137-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073137-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073137-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073137-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073137-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073137-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073137-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073137-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073137-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073137-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073137-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073137-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073137-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073137-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073137-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073137-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073137-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073137-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073137-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073137-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073137-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073137-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073137-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073137-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073137-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073137-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073137-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073137-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073137-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073137-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073137-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073137-001AB11e350fbaab3a…

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
66116-357-30Trazodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-357TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130822_9426f88d-2f3f-4dc9-ba17-f4bc0be91963.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856377traZODone HCl 50 MG Oral TabletPSN9426f88d-2f3f-4dc9-ba17-f4bc0be919631
856377trazodone hydrochloride 50 MG Oral TabletSCD9426f88d-2f3f-4dc9-ba17-f4bc0be919631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-357-306611603573030 in 1 BOTTLE, PLASTICHistorical