Clorazepate Dipotassium

Product NDC: 58118-4042
11-digit product format: 581184042
Labeler code: 58118
Product ID: 58118-4042_57629108-6ad4-cd5a-e063-6394a90a2a1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clorazepate Dipotassium
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075731-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	2000-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075731-002	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB	2000-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075731-003	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB	2000-04-27	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075731-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075731-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075731-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075731-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075731-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075731-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLORAZEPATE DIPOTASSIUM	3.75 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197464	Internal RxNorm lookup
197465	Internal RxNorm lookup
197466	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
11b72861-64c9-4cdc-9289-c7fa9ea23bf6	Available on FDA.report

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 · 5 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 ndc (product): 58118-4042
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	Coupler LLC	2ccaf945-0369-3129-e063-6394a90a2740	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075731 application number: ANDA075731
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58118-4042-8	58118404208	30 TABLET in 1 BLISTER PACK (58118-4042-8)	30 tablet	2026-07-24	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	Clinical Solutions Wholesale, LLC	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1