Trazodone Hydrochloride

Product NDC
55700-844
11-digit product format
557000844
Labeler code
55700
Product ID
55700-844_b70a75b3-27e0-4a64-8e89-b80a12e935e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA206923
Marketing category
ANDA
Marketing start
2020-02-21
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-844DDiscontinued by firm2026-08-17
excluded packagepackage55700-84455700-844-30DDiscontinued by firm2026-08-17
excluded packagepackage55700-84455700-844-60DDiscontinued by firm2026-08-17

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 · 52 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-844-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-844-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-844-60DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-844-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-844-60DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-844-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-844-60DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-844-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-844-60DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-844-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-844-60DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-844-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-844-60DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-844-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-844-60DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-844-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-844-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-844-90IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-844-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-844-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-844-90IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-844-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-844-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-844-90IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-844-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-844-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-844-90IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-844-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-844-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-844-90IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-844-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-844-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-844-90IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-844-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-844-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-844-90IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-844-30IInactivated by FDA1332a3947898…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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
55700-844-302025-01-13These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
55700-844-602025-01-13These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
55700-844-902025-01-13These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
55700-844-302024-01-30These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
55700-844-602024-01-30These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
55700-844-902024-01-30These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-844-30EA - Each55700-844f03c9240-7161-4b74-b1c2-0c4881f73a3312020-03-10
55700-844-60EA - Each55700-844b383b2d7-0f30-4cf9-a9f7-18139f4cbe6912021-03-02
55700-844-90EA - Each55700-844358eac6c-a8b1-407e-94da-edca6ee9606112021-04-08

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-844-305570008443030 TABLET in 1 BOTTLE (55700-844-30) 30 tablet2020-02-210000-00-00NoNoCurrent
55700-844-605570008446060 TABLET in 1 BOTTLE (55700-844-60) 60 tablet2021-02-030000-00-00NoNoCurrent
55700-844-905570008449090 TABLET in 1 BOTTLE (55700-844-90) 90 tablet2021-03-090000-00-00NoNoCurrent