Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC: 71335-2966
11-digit product format: 713352966
Labeler code: 71335
Product ID: 71335-2966_294e32f3-6d8f-4bb8-95dd-55449a17e01e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211421
Marketing category: ANDA
Marketing start: 2020-07-09
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Active strength: 5; 2.5 mg/1; mg/1
Pharmacologic classes: Anticholinergic [EPC], Benzodiazepine [EPC], Benzodiazepines [CS], Cholinergic Antagonists [MoA], Decreased Parasympathetic Acetylcholine Activity [PE], Digestive/GI System Activity Alteration [PE], GI Motility Alteration [PE]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB		2020-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211421-001	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.

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	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211421-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2020-07-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211421-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211421-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211421-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211421-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211421-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211421-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211421-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211421-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211421-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211421-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211421-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211421-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211421-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211421-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211421-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211421-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211421-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211421-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211421-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211421-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211421-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211421-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211421-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211421-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211421-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211421-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211421-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211421-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211421-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211421-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211421-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211421-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211421-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211421-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211421-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211421-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211421-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211421-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211421-001	AB	1	`a50c72e98297…`

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: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE	5 mg/1
CLIDINIUM BROMIDE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MFM6K1XWDK	Internal UNII lookup
91ZQW5JF1Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
889614	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
d4ed59f7-7624-480f-b151-2d4e9b6b7013	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
632cace7-5e66-44d3-b8c3-9d6af8cdd96a	Product name	5	20250623
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2966-1	Chlordiazepoxide Hydrochloride and Clidinium Bromide	100 in 1 BOTTLE	CAPSULE	100		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2966-1	EA - Each	71335-2966	f9dc4b0c-c697-4208-81bf-7a4924b16a51	1	2026-02-05

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
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	d4ed59f7-7624-480f-b151-2d4e9b6b7013	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211421 application number: ANDA211421 ndc (product): 71335-2966
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	160c6524-314f-404a-ac04-0f3bfae2fde3	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211421 application number: ANDA211421
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	68d8dca6-697d-401e-acaf-01bfe4c4da17	2023-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211421 application number: ANDA211421
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	c3223f35-1baf-46bf-9eb3-55455f672d85	2023-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211421 application number: ANDA211421
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Sunrise Pharmaceutical, Inc.	3cce1912-e7c8-4f30-bd76-dfa4b9d65bac	2022-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211421 application number: ANDA211421

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE	438-41-5	CHLORDIAZEPOXIDE HYDROCHLORIDE
91ZQW5JF1Z	CLIDINIUM BROMIDE	3485-62-9	CLIDINIUM BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
889614	chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral Capsule	PSN	d4ed59f7-7624-480f-b151-2d4e9b6b7013	100
889614	chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule	SCD	d4ed59f7-7624-480f-b151-2d4e9b6b7013	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2966-1	71335296601	100 CAPSULE in 1 BOTTLE (71335-2966-1)	100 capsule	2026-01-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP for oral use	Bryant Ranch Prepack	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	100