Clorazepate Dipotassium

Product NDC: 21695-433
11-digit product format: 216950433
Labeler code: 21695
Product ID: 21695-433_a6cc08b8-146e-430f-af39-8b866698b997
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clorazepate Dipotassium
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075731
Marketing category: ANDA
Marketing start: 2000-04-27
Marketing end: 0000-00-00
Substance: CLORAZEPATE DIPOTASSIUM
Active strength: 4 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-433		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-433	21695-433-60	I	Inactivated by FDA		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 · 44 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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`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	21695-433-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-433-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-433-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-433-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-433-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-433-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-433-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-433-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-433-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-433-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-433-60	`110d247fa046…`	`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-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…`

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
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-433-60	2019-09-24	C162847	48780-1	934fe258-4842-48b1-e053-8cdaa90a720a	Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-433-60	Clorazepate Dipotassium	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-433-60	EA - Each	21695-433	2a6db680-9c52-41a1-a7c9-d158ddd0282a	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 [REBEL DISTRIBUTORS CORP]	1
Clorazepic acid	ACTIVE MOIETY	D51WO0G0L4	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
POTASSIUM CARBONATE	INACTIVE INGREDIENT	BQN1B9B9HA	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
potassium chloride	INACTIVE INGREDIENT	660YQ98I10	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-433	CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20101220_a6cc08b8-146e-430f-af39-8b866698b997.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
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
197465	clorazepate dipotassium 3.75 MG Oral Tablet	PSN	a6cc08b8-146e-430f-af39-8b866698b997	1
197466	clorazepate dipotassium 7.5 MG Oral Tablet	PSN	a6cc08b8-146e-430f-af39-8b866698b997	1
197465	clorazepate dipotassium 3.75 MG Oral Tablet	SCD	a6cc08b8-146e-430f-af39-8b866698b997	1
197466	clorazepate dipotassium 7.5 MG Oral Tablet	SCD	a6cc08b8-146e-430f-af39-8b866698b997	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-433-60	21695043360	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mg	Rebel Distributors Corp	2010-12-16	HUMAN PRESCRIPTION DRUG LABEL	1