Tranxene

Product NDC
55292-304
Requested package NDC
55292-304-01
11-digit product format
552920304
Labeler code
55292
Product ID
55292-304_1aad278c-14c5-4b8a-ad70-ce61a220936e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clorazepate dipotassium
Dosage form
TABLET
Route
ORAL
Labeler
Recordati Rare Diseases, Inc.
Application
NDA017105
Marketing category
NDA
Marketing start
1972-06-23
Marketing end
2023-01-31
Substance
CLORAZEPATE DIPOTASSIUM
Active strength
8 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
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 packagepackage55292-30455292-304-01DDiscontinued by firm2026-08-11

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017105-001TRANXENECLORAZEPATE DIPOTASSIUM3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017105-002TRANXENECLORAZEPATE DIPOTASSIUM7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017105-003TRANXENECLORAZEPATE DIPOTASSIUM15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017105-004TRANXENE SDCLORAZEPATE DIPOTASSIUM22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017105-005TRANXENE SDCLORAZEPATE DIPOTASSIUM11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017105-006TRANXENECLORAZEPATE DIPOTASSIUM3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N017105-007TRANXENECLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALABRLD, Approved before 1982
N017105-008TRANXENECLORAZEPATE DIPOTASSIUM15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017105-007AB

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 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-001TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-002TRANXENE7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-003TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-004TRANXENE SD22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-005TRANXENE SD11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-006TRANXENE3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-007TRANXENE7.5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-008TRANXENE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…

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 UTC2026-02N017105-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017105-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017105-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017105-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017105-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017105-007AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017105-007AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017105-007AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017105-007AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017105-007AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017105-007AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017105-007AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017105-007AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017105-007AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017105-007AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017105-007AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017105-007AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017105-007AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017105-007AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017105-007AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017105-007AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017105-007AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017105-007AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017105-007AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017105-007AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017105-007AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017105-007AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017105-007AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017105-007AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017105-007AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017105-007AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017105-007AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017105-007AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017105-007AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017105-007AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017105-007AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017105-007AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017105-007AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017105-007AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017105-007AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-304-01EA - Each55292-30451441b07-3814-4470-8024-c0741fb177ea12018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLORAZEPATE DIPOTASSIUMACTIVE INGREDIENT63FN7G03XYTRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
CLORAZEPIC ACIDACTIVE MOIETYD51WO0G0L4TRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GTRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
POTASSIUM CARBONATEINACTIVE INGREDIENTBQN1B9B9HATRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10TRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRANXENE T-TAB (CLORAZEPATE DIPOTASSIUM) TABLET [RECORDATI RARE DISEASES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55292-304-0155292030401100 TABLET in 1 BOTTLE (55292-304-01) 100 tablet1972-06-232023-01-31NoNoCurrent