Clorazepate Dipotassium

Product NDC: 67046-1501
Requested package NDC: 67046-1501-3
11-digit product format: 670461501
Labeler code: 67046
Product ID: 67046-1501_2ccafa6f-08ea-91c7-e063-6294a90aa353
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clorazepate Dipotassium
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA075731
Marketing category: ANDA
Marketing start: 2025-01-28
Substance: CLORAZEPATE DIPOTASSIUM
Active strength: 15 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075731-001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27
A075731-002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27
A075731-003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075731-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075731-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075731-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075731-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075731-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075731-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075731-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075731-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075731-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075731-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075731-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075731-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075731-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075731-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075731-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075731-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075731-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clorazepate Dipotassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLORAZEPATE DIPOTASSIUM	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63FN7G03XY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197464	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2ccaf945-0369-3129-e063-6394a90a2740	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
92da8c14-4fd1-b0be-b744-e53fd3862208	Product name	2	20230310
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1501-3	Clorazepate Dipotassium	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1501	CLORAZEPATE DIPOTASSIUM TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250130_2ccaf945-0369-3129-e063-6394a90a2740.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Clinical Solutions Wholesale, LLC	11b72861-64c9-4cdc-9289-c7fa9ea23bf6	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Sun Pharmaceutical Industries, Inc.	499a6989-8912-44b7-b1eb-ee8f85ae378f	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	40074ed8-0799-e3e0-e063-6394a90ad200	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	PD-Rx Pharmaceuticals, Inc.	7b59a3ab-3dff-4458-a63a-ef0d9e0d996d	2025-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	Coupler LLC	2ccaf945-0369-3129-e063-6394a90a2740	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731 ndc (package): 67046-1501-3 ndc (product): 67046-1501 ndc11 (package): 67046150103
Clorazepate Dipotassium	CLORAZEPATE DIPOTASSIUM	NORTHSTAR RX LLC	fb5c9e98-02b2-4c36-b436-25b58fe3c7d5	2024-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63FN7G03XY	CLORAZEPATE DIPOTASSIUM	57109-90-7	CLORAZEPATE DIPOTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197464	clorazepate dipotassium 15 MG Oral Tablet	PSN	2ccaf945-0369-3129-e063-6394a90a2740	1
197464	clorazepate dipotassium 15 MG Oral Tablet	SCD	2ccaf945-0369-3129-e063-6394a90a2740	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1501-3	67046150103	30 TABLET in 1 BLISTER PACK (67046-1501-3)	30 tablet	2025-01-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mg	Coupler LLC	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	1