Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC: 63629-8859
11-digit product format: 636298859
Labeler code: 63629
Product ID: 63629-8859_2dfb04f3-194a-4d76-aa25-193790b80e9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA214065
Marketing category: ANDA
Marketing start: 2021-04-27
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB		2021-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214065-001	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
2026-08-18 06:07:40	2026-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214065-001	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	2021-04-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214065-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214065-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214065-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214065-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214065-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214065-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214065-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214065-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214065-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214065-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214065-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214065-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214065-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214065-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214065-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214065-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214065-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214065-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214065-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214065-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214065-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214065-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214065-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214065-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214065-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214065-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214065-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214065-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214065-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214065-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214065-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214065-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214065-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214065-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Listing expiration: 2026-12-31

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
01d1e922-f3a8-4af3-99ec-94b927187373	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
63629-8859-1	Chlordiazepoxide Hydrochloride and Clidinium Bromide	100 in 1 BOTTLE	CAPSULE	100		107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8859-1	EA - Each	63629-8859	3583cf1a-07c4-40b9-b2db-5b5a8a00c3fd	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8859	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BRYANT RANCH PREPACK]	107	Current NDC, Legacy NDC, 1 package rows	20240809_01d1e922-f3a8-4af3-99ec-94b927187373.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 · 3 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	Ascend Laboratories, LLC	19fdde81-e0f2-4269-bd57-252a759b7593	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214065 application number: ANDA214065
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	American Health Packaging	0fb80410-4689-4b8e-bfbb-19a62c9fe888	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214065 application number: ANDA214065
Chlordiazepoxide Hydrochloride and Clidinium Bromide	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bryant Ranch Prepack	01d1e922-f3a8-4af3-99ec-94b927187373	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214065 application number: ANDA214065 ndc (product): 63629-8859

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	01d1e922-f3a8-4af3-99ec-94b927187373	107
889614	chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule	SCD	01d1e922-f3a8-4af3-99ec-94b927187373	107

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8859-1	63629885901	100 CAPSULE in 1 BOTTLE (63629-8859-1)	100 capsule	2021-04-27	0000-00-00	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	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	107