FDA.reportPublic FDA data

Clorazepate Dipotassium

Product NDC
51672-4042
11-digit product format
516724042
Labeler code
51672
Product ID
51672-4042_22e382fc-edce-24b7-e063-6394a90a35e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clorazepate Dipotassium
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA075731
Marketing category
ANDA
Marketing start
2000-04-27
Substance
CLORAZEPATE DIPOTASSIUM
Active strength
3.75 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A075731-001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27
A075731-002CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27
A075731-003CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075731-001AB
A075731-002AB
A075731-003AB

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 UTC2026-02A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075731-002CLORAZEPATE DIPOTASSIUM7.5MGTABLET / ORALAB2000-04-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075731-003CLORAZEPATE DIPOTASSIUM3.75MGTABLET / ORALAB2000-04-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075731-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORALAB2000-04-278072bd15b7f6…

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 UTC2026-02A075731-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075731-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075731-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075731-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075731-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075731-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075731-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075731-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075731-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075731-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075731-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075731-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075731-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075731-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075731-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075731-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075731-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075731-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075731-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075731-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075731-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075731-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075731-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075731-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075731-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075731-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075731-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075731-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075731-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075731-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075731-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075731-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075731-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075731-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075731-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075731-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075731-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075731-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075731-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075731-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Clorazepate Dipotassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLORAZEPATE DIPOTASSIUM3.75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63FN7G03XYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197464Internal RxNorm lookup
197465Internal RxNorm lookup
197466Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
499a6989-8912-44b7-b1eb-ee8f85ae378fAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4042-1Clorazepate Dipotassium100 in 1 BOTTLETABLET1007
51672-4042-2Clorazepate Dipotassium500 in 1 BOTTLETABLET5007
51672-4042-3Clorazepate Dipotassium1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4042-1EA - Each51672-40420ea7a82a-26de-4b5a-9315-c41ad50f087d12012-07-24
51672-4042-2EA - Each51672-40421ff5ed09-17d7-470e-814d-090d365b7a2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clorazepate DipotassiumACTIVE INGREDIENT63FN7G03XYCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Clorazepic AcidACTIVE MOIETYD51WO0G0L4CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Clorazepate DipotassiumACTIVE INGREDIENT63FN7G03XYCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
Clorazepic acidACTIVE MOIETYD51WO0G0L4CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
POTASSIUM CARBONATEINACTIVE INGREDIENTBQN1B9B9HACLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
potassium chlorideINACTIVE INGREDIENT660YQ98I10CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4042CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 3 package rows20240926_499a6989-8912-44b7-b1eb-ee8f85ae378f.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMClinical Solutions Wholesale, LLC11b72861-64c9-4cdc-9289-c7fa9ea23bf62026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075731
application number: ANDA075731
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMSun Pharmaceutical Industries, Inc.499a6989-8912-44b7-b1eb-ee8f85ae378f2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075731
application number: ANDA075731
ndc (product): 51672-4042
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC40074ed8-0799-e3e0-e063-6394a90ad2002025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075731
application number: ANDA075731
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMPD-Rx Pharmaceuticals, Inc.7b59a3ab-3dff-4458-a63a-ef0d9e0d996d2025-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075731
application number: ANDA075731
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2ccaf945-0369-3129-e063-6394a90a27402025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075731
application number: ANDA075731
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMNORTHSTAR RX LLCfb5c9e98-02b2-4c36-b436-25b58fe3c7d52024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075731
application number: ANDA075731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197464clorazepate dipotassium 15 MG Oral TabletPSN499a6989-8912-44b7-b1eb-ee8f85ae378f7
197465clorazepate dipotassium 3.75 MG Oral TabletPSN499a6989-8912-44b7-b1eb-ee8f85ae378f7
197466clorazepate dipotassium 7.5 MG Oral TabletPSN499a6989-8912-44b7-b1eb-ee8f85ae378f7
197464clorazepate dipotassium 15 MG Oral TabletSCD499a6989-8912-44b7-b1eb-ee8f85ae378f7
197465clorazepate dipotassium 3.75 MG Oral TabletSCD499a6989-8912-44b7-b1eb-ee8f85ae378f7
197466clorazepate dipotassium 7.5 MG Oral TabletSCD499a6989-8912-44b7-b1eb-ee8f85ae378f7
197465clorazepate dipotassium 3.75 MG Oral TabletPSNa6cc08b8-146e-430f-af39-8b866698b9971
197466clorazepate dipotassium 7.5 MG Oral TabletPSNa6cc08b8-146e-430f-af39-8b866698b9971
197465clorazepate dipotassium 3.75 MG Oral TabletSCDa6cc08b8-146e-430f-af39-8b866698b9971
197466clorazepate dipotassium 7.5 MG Oral TabletSCDa6cc08b8-146e-430f-af39-8b866698b9971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4042-151672404201100 TABLET in 1 BOTTLE (51672-4042-1) 100 tablet2000-04-270000-00-00NoNoCurrent
51672-4042-251672404202500 TABLET in 1 BOTTLE (51672-4042-2) 500 tablet2000-04-270000-00-00NoNoCurrent
51672-4042-3516724042031000 TABLET in 1 BOTTLE (51672-4042-3) 1000 tablet2000-04-270000-00-00NoNoCurrent