Clorazepate Dipotassium

Product NDC
67046-906
11-digit product format
670460906
Labeler code
67046
Product ID
67046-906_7abac94c-ba0e-415b-9196-72caf153cc7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clorazepate Dipotassium
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA071858
Marketing category
ANDA
Marketing start
2011-03-29
Marketing end
0000-00-00
Substance
CLORAZEPATE DIPOTASSIUM
Active strength
8 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
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 productproduct67046-906IInactivated by FDA2026-08-11
excluded packagepackage67046-90667046-906-30IInactivated 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 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 packagepackage67046-906-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-906-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-906-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-906-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-906-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-906-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-906-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-906-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-906-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-906-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-906-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-906-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-906-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-906-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-906-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-906-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-906-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-906-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67046-906-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67046-906-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67046-906-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67046-906-30110d247fa046…a55b01930146…

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
A071858-001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17
A071858-002CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17
A071858-003CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071858-001AB
A071858-002AB
A071858-003AB

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 · 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 UTC2026-02A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071858-002CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB1987-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071858-003CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB1987-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071858-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALABRS1987-07-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071858-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071858-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071858-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071858-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071858-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071858-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071858-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071858-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071858-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071858-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071858-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071858-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071858-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071858-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071858-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071858-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071858-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071858-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071858-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071858-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
92da8c14-4fd1-b0be-b744-e53fd3862208Product name220230310
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-906-302019-10-29C16284748780-1960f7f55-c8ab-8e05-e053-dbdaa90a074aClorazepate Dipotassium Tablets USP, 7.5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-906-30Clorazepate Dipotassium30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-906CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20110517_7abac94c-ba0e-415b-9196-72caf153cc7c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC919cbd07-f587-4005-acff-26213dd1d1fb2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071858
application number: ANDA071858
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC69451c35-dd9a-4690-8d5e-4dcfa88376202024-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071858
application number: ANDA071858

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197466clorazepate dipotassium 7.5 MG Oral TabletPSN7abac94c-ba0e-415b-9196-72caf153cc7c1
197466clorazepate dipotassium 7.5 MG Oral TabletSCD7abac94c-ba0e-415b-9196-72caf153cc7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-906-306704609063030 in 1 BLISTER PACKHistorical