Clorazepate Dipotassium

Product NDC: 0378-0040
11-digit product format: 003780040
Labeler code: 0378
Product ID: 0378-0040_21627ba9-f1e6-4251-b3fc-8836c1f7266f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clorazepate dipotassium
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA071858
Marketing category: ANDA
Marketing start: 1987-07-17
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: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-0040		D	Discontinued by firm	2026-08-11
excluded package	package	0378-0040	0378-0040-01	D	Discontinued by firm	2026-08-11
excluded package	package	0378-0040	0378-0040-05	D	Discontinued by firm	2026-08-11

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0040-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0040-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0040-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0040-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0040-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0040-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0040-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0040-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0040-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0040-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0040-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0040-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0040-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0040-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0040-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0040-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0040-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0040-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0040-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0040-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0040-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0040-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0040-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0040-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
A071858-001	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17
A071858-002	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17
A071858-003	CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071858-001	AB
A071858-002	AB
A071858-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-002	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET / ORAL	AB		1987-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-003	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET / ORAL	AB		1987-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071858-001	CLORAZEPATE DIPOTASSIUM	15MG	TABLET / ORAL	AB	RS	1987-07-17	`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	A071858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071858-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071858-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071858-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071858-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071858-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071858-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071858-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071858-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071858-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071858-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071858-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071858-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071858-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071858-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071858-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
92da8c14-4fd1-b0be-b744-e53fd3862208	Product name	2	20230310
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0040-01	EA - Each	0378-0040	8886ef2f-abdf-4dff-b467-f7cfd570067c	1	2012-07-24
0378-0040-05	EA - Each	0378-0040	4ca46786-d66f-4d8b-a891-b5492e960821	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLORAZEPATE DIPOTASSIUM	ACTIVE INGREDIENT	63FN7G03XY	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
CLORAZEPIC ACID	ACTIVE MOIETY	D51WO0G0L4	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
POTASSIUM CARBONATE	INACTIVE INGREDIENT	BQN1B9B9HA	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.]	5
CLORAZEPATE DIPOTASSIUM	ACTIVE INGREDIENT	63FN7G03XY	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CLORAZEPIC ACID	ACTIVE MOIETY	D51WO0G0L4	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POTASSIUM CARBONATE	INACTIVE INGREDIENT	BQN1B9B9HA	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLORAZEPATE DIPOTASSIUM TABLET [CONTRACT PHARMACY SERVICES-PA]	1

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma LLC	919cbd07-f587-4005-acff-26213dd1d1fb	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071858 application number: ANDA071858
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	Aurolife Pharma LLC	69451c35-dd9a-4690-8d5e-4dcfa8837620	2024-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071858 application number: ANDA071858

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
197466	clorazepate dipotassium 7.5 MG Oral Tablet	PSN	7abac94c-ba0e-415b-9196-72caf153cc7c	1
197466	clorazepate dipotassium 7.5 MG Oral Tablet	SCD	7abac94c-ba0e-415b-9196-72caf153cc7c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0040-01	00378004001	100 TABLET in 1 BOTTLE, PLASTIC (0378-0040-01)	100 tablet	1987-07-17	0000-00-00	No	No	Current
0378-0040-05	00378004005	500 TABLET in 1 BOTTLE, PLASTIC (0378-0040-05)	500 tablet	1987-07-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clorazepate Dipotassium - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2020-06-30	HUMAN PRESCRIPTION DRUG LABEL	10
Clorazepate Dipotassium Tablets USP, 7.5 mg	Contract Pharmacy Services-PA	2010-12-16	HUMAN PRESCRIPTION DRUG LABEL	1