Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC: 42582-300
11-digit product format: 425820300
Labeler code: 42582
Product ID: 42582-300_6b280638-de5a-41f5-8005-86cb00187c81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form: CAPSULE
Route: ORAL
Labeler: Bi-Coastal Pharmaceutical Corporation
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-05-04
Marketing end: 0000-00-00
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42582-300		I	Inactivated by FDA	2026-10-05
excluded package	package	42582-300	42582-300-10	I	Inactivated by FDA	2026-10-05
excluded package	package	42582-300	42582-300-16	I	Inactivated by FDA	2026-10-05
excluded package	package	42582-300	42582-300-20	I	Inactivated by FDA	2026-10-05

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 2 · 88 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	42582-300-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42582-300-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42582-300-10	`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	42582-300-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42582-300-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42582-300-10	`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	42582-300-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42582-300-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42582-300-10	`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	42582-300-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42582-300-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42582-300-10	`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	42582-300-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42582-300-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42582-300-10	`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	42582-300-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42582-300-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42582-300-10	`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	42582-300-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42582-300-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42582-300-10	`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	42582-300-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42582-300-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42582-300-10	`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	42582-300-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42582-300-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42582-300-10	`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	42582-300-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42582-300-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42582-300-10	`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	42582-300-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42582-300-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42582-300-10	`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	42582-300-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42582-300-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42582-300-10	`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	42582-300-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42582-300-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42582-300-10	`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	42582-300-16	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42582-300-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42582-300-10	`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	42582-300-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42582-300-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42582-300-10	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42582-300-10	2019-11-13	C162847	48780-1	97449f38-bda1-f6ea-e053-dbdaa90aa703	Chlordiazepoxide HCl and Clidinium Bromide Capsules
42582-300-16	2019-11-13	C162847	48780-1	97449f38-bda1-f6ea-e053-dbdaa90aa703	Chlordiazepoxide HCl and Clidinium Bromide Capsules
42582-300-20	2019-11-13	C162847	48780-1	97449f38-bda1-f6ea-e053-dbdaa90aa703	Chlordiazepoxide HCl and Clidinium Bromide Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42582-300-10	Chlordiazepoxide Hydrochloride and Clidinium Bromide	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	1
42582-300-16	Chlordiazepoxide Hydrochloride and Clidinium Bromide	250 in 1 BOTTLE, PLASTIC	CAPSULE	250	1
42582-300-20	Chlordiazepoxide Hydrochloride and Clidinium Bromide	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42582-300-10	EA - Each	42582-300	2c69b3e1-06ac-4a3a-bb58-6f142aa57e78	1	2012-07-24
42582-300-16	EA - Each	42582-300	f4eed5a4-60ba-4ee9-a2e1-15d4f836c17d	1	2014-07-02
42582-300-20	EA - Each	42582-300	08e15b85-37f9-47fd-8f39-1259c997d2b5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlordiazepoxide Hydrochloride	ACTIVE INGREDIENT	MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Clidinium Bromide	ACTIVE INGREDIENT	91ZQW5JF1Z	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Chlordiazepoxide	ACTIVE MOIETY	6RZ6XEZ3CR	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Clidinium	ACTIVE MOIETY	BO76JF850N	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
FD&C Green No. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42582-300	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMACEUTICAL CORPORATION]	1	Legacy NDC, 3 package rows	20120613_69e56e41-8413-4439-8cc0-caf17d60526d.zip

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	69e56e41-8413-4439-8cc0-caf17d60526d	1
889614	chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule	SCD	69e56e41-8413-4439-8cc0-caf17d60526d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42582-300-10	42582030010	100 in 1 BOTTLE, PLASTIC	Historical
42582-300-16	42582030016	250 in 1 BOTTLE, PLASTIC	Historical
42582-300-20	42582030020	1000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide HCl and Clidinium Bromide Capsules	Bi-Coastal Pharmaceutical Corporation \| ECI Pharmaceuticals LLC	2012-06-12	HUMAN PRESCRIPTION DRUG LABEL	1