Trazodone Hydrochloride

Product NDC
63629-3210
Requested package NDC
63629-3210-6
11-digit product format
636293210
Labeler code
63629
Product ID
63629-3210_c3478688-77e0-09b0-0653-5716b2de5042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071524
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
2022-07-31
Substance
TRAZODONE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-321063629-3210-6DDiscontinued 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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071524-001TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071524-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071524-001TRAZODONE HYDROCHLORIDE100MGTABLET / ORALAB1987-12-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071524-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071524-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071524-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071524-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071524-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071524-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071524-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071524-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071524-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071524-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071524-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071524-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071524-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071524-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071524-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071524-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071524-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071524-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071524-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071524-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071524-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071524-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071524-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071524-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071524-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071524-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071524-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071524-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071524-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071524-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071524-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071524-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071524-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071524-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071524-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071524-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071524-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071524-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071524-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071524-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3210-12020-10-16These 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
63629-3210-22020-10-16These 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
63629-3210-32020-10-16These 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
63629-3210-42020-10-16These 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
63629-3210-52020-10-16These 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
63629-3210-62020-10-16These 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
63629-3210-72020-10-16These 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
63629-3210-82020-10-16These 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
63629-3210-92020-10-16These 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
63629-3210-12020-01-31These 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
63629-3210-22020-01-31These 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
63629-3210-32020-01-31These 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
63629-3210-42020-01-31These 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
63629-3210-52020-01-31These 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
63629-3210-62020-01-31These 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
63629-3210-72020-01-31These 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
63629-3210-82020-01-31These 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
63629-3210-92020-01-31These 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
63629-3210-1EA - Each63629-3210e1d134a8-badc-4538-8ea2-aaf393a4c9eb12012-07-24
63629-3210-2EA - Each63629-3210ab7f7b77-a9c1-45dc-8e19-6f7daedd2c5512012-07-24
63629-3210-3EA - Each63629-3210bc41f81f-d327-4e35-9983-5fcd0f61378212012-07-24
63629-3210-4EA - Each63629-321002204ee5-a23c-4ba4-8b29-6b1deb1a86df12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAZODONE HYDROCHLORIDEACTIVE INGREDIENT6E8ZO8LRNMTRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
TRAZODONEACTIVE MOIETYYBK48BXK30TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsdf17cec9-ad5e-4e57-8572-c927c9b955e22026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEREMEDYREPACK INC.7bba99e5-4096-4fcb-8591-dc4a9bfe975e2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREb3723265-7455-c25c-e053-2a95a90a379b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b617348c-cb19-45df-b313-4ea6af6f1dda2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCe07d7ee3-776d-1fa3-e053-2a95a90a70192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071524
application number: ANDA071524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3210-66362932100610 TABLET in 1 BOTTLE (63629-3210-6) 10 tablet2011-09-152022-07-31NoNoCurrent