Librax

Product NDC: 0187-4100
11-digit product format: 001874100
Labeler code: 0187
Product ID: 0187-4100_98fd8b52-2fc3-4540-8333-75b5c853aee2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form: CAPSULE
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA012750
Marketing category: NDA
Marketing start: 1966-09-01
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]
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 1.

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
N012750-001	LIBRAX	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N012750-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012750-001	LIBRAX	5MG;2.5MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012750-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012750-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012750-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012750-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012750-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012750-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012750-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012750-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012750-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012750-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012750-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012750-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012750-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012750-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012750-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012750-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012750-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N012750-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012750-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012750-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012750-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012750-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012750-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012750-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012750-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012750-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012750-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012750-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012750-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012750-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012750-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012750-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012750-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012750-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012750-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012750-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N012750-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Librax
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
889614	Internal RxNorm lookup
889616	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
f99ebf66-f207-4a97-9666-4da1d72b061c	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
0187-4100-10	Librax	100 in 1 BOTTLE	CAPSULE	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-4100-10	EA - Each	0187-4100	085cffe6-08d9-4e06-bf11-271d2c6381fc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlordiazepoxide Hydrochloride	ACTIVE INGREDIENT	MFM6K1XWDK	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
Clidinium Bromide	ACTIVE INGREDIENT	91ZQW5JF1Z	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
Chlordiazepoxide	ACTIVE MOIETY	6RZ6XEZ3CR	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
CLIDINIUM	ACTIVE MOIETY	BO76JF850N	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
FD&C Green No. 3	INACTIVE INGREDIENT	3P3ONR6O1S	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VALEANT PHARMACEUTICALS INTERNATIONAL]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-4100	LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [BAUSCH HEALTH US, LLC]	16	Current NDC, Legacy NDC, 1 package rows	20230425_f99ebf66-f207-4a97-9666-4da1d72b061c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Librax	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	Bausch Health US, LLC	f99ebf66-f207-4a97-9666-4da1d72b061c	2023-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 012750 application number: NDA012750 ndc (product): 0187-4100

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	f99ebf66-f207-4a97-9666-4da1d72b061c	16
889616	Librax 5 MG / 2.5 MG Oral Capsule	PSN	f99ebf66-f207-4a97-9666-4da1d72b061c	16
889616	chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule [Librax]	SBD	f99ebf66-f207-4a97-9666-4da1d72b061c	16
889614	chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral Capsule	SCD	f99ebf66-f207-4a97-9666-4da1d72b061c	16
889616	Librax (chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG) Oral Capsule	SY	f99ebf66-f207-4a97-9666-4da1d72b061c	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-4100-10	00187410010	100 CAPSULE in 1 BOTTLE (0187-4100-10)	100 capsule	1966-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIBRAX ® (chlordiazepoxide hydrochloride and clidinium bromide) Capsules for oral use	Bausch Health US, LLC \| Bausch Health Companies Inc.	2023-01-13	HUMAN PRESCRIPTION DRUG LABEL	16