Clorazepate dipotassium

Product NDC
63304-554
11-digit product format
633040554
Labeler code
63304
Product ID
63304-554_9288b398-2811-4f9b-a088-c719de4dc8f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clorazepate dipotassium
Dosage form
TABLET
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076911
Marketing category
ANDA
Marketing start
2005-01-14
Marketing end
0000-00-00
Substance
CLORAZEPATE DIPOTASSIUM
Active strength
15 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63304-554IInactivated by FDA2026-08-11
excluded packagepackage63304-55463304-554-01IInactivated by FDA2026-08-11
excluded packagepackage63304-55463304-554-10IInactivated by FDA2026-08-11
excluded packagepackage63304-55463304-554-30IInactivated by FDA2026-08-11

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 2 · 88 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 packagepackage63304-554-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-554-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-554-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-554-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-554-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-554-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-554-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-554-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-554-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-554-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-554-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-554-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-554-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-554-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-554-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-554-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-554-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-554-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-554-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-554-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-554-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-554-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-554-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-554-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-554-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-554-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-554-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-554-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-554-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-554-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-554-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-554-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-554-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-554-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-554-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-554-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63304-554-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63304-554-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63304-554-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63304-554-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63304-554-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63304-554-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63304-554-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63304-554-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63304-554-101332a3947898…d4bfe170f9cd…

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

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
A076911-001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29
A076911-002CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29
A076911-003CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076911-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORAL2004-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076911-003CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL2004-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076911-001CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORAL2004-09-298072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
92da8c14-4fd1-b0be-b744-e53fd3862208Product name220230310
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-554-01Clorazepate dipotassium100 in 1 BOTTLETABLET1002
63304-554-10Clorazepate dipotassium1000 in 1 BOTTLETABLET10002
63304-554-30Clorazepate dipotassium30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-554-01EA - Each63304-5545daf066a-d28e-4095-90d0-a39307c4e62612013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-554CLORAZEPATE DIPOTASSIUM TABLET [RANBAXY PHARMACEUTICALS INC.]2Legacy NDC, 3 package rows20120912_6e9edbfc-1950-4893-9d38-e82b119ddb9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197464clorazepate dipotassium 15 MG Oral TabletPSN6e9edbfc-1950-4893-9d38-e82b119ddb9a2
197465clorazepate dipotassium 3.75 MG Oral TabletPSN6e9edbfc-1950-4893-9d38-e82b119ddb9a2
197466clorazepate dipotassium 7.5 MG Oral TabletPSN6e9edbfc-1950-4893-9d38-e82b119ddb9a2
197464clorazepate dipotassium 15 MG Oral TabletSCD6e9edbfc-1950-4893-9d38-e82b119ddb9a2
197465clorazepate dipotassium 3.75 MG Oral TabletSCD6e9edbfc-1950-4893-9d38-e82b119ddb9a2
197466clorazepate dipotassium 7.5 MG Oral TabletSCD6e9edbfc-1950-4893-9d38-e82b119ddb9a2
197464clorazepate dipotassium 15 MG Oral TabletPSN5a409d46-bebf-1e76-e053-2a91aa0ac6261
197466clorazepate dipotassium 7.5 MG Oral TabletPSN5a409d46-bebf-1e76-e053-2a91aa0ac6261
197464clorazepate dipotassium 15 MG Oral TabletSCD5a409d46-bebf-1e76-e053-2a91aa0ac6261
197466clorazepate dipotassium 7.5 MG Oral TabletSCD5a409d46-bebf-1e76-e053-2a91aa0ac6261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-554-0163304055401100 in 1 BOTTLEHistorical
63304-554-10633040554101000 in 1 BOTTLEHistorical
63304-554-306330405543030 in 1 BOTTLEHistorical