Chlordiazepoxide Hydrochloride/Clidinium Bromide

Product NDC
76439-302
Requested package NDC
76439-302-10
11-digit product format
764390302
Labeler code
76439
Product ID
76439-302_f31923b6-a244-4cc3-957e-807b2e2cac24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Virtus Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-06-08
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
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76439-30276439-302-10DDiscontinued by firm2026-10-12

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 conceptRelationVersionEffective
632cace7-5e66-44d3-b8c3-9d6af8cdd96aProduct name520250623
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76439-302-10EA - Each76439-302258c38ed-6c53-4bff-a0d3-d4c75047993012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlordiazepoxide HydrochlorideACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
Clidinium BromideACTIVE INGREDIENT91ZQW5JF1ZCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
ChlordiazepoxideACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
ClidiniumACTIVE MOIETYBO76JF850NCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
FD&C green no. 3INACTIVE INGREDIENT3P3ONR6O1SCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
gelatinINACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
starch, cornINACTIVE INGREDIENTO8232NY3SJCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
talcINACTIVE INGREDIENT7SEV7J4R1UCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [VIRTUS PHARMACEUTICALS]2
Chlordiazepoxide HydrochlorideACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
Clidinium BromideACTIVE INGREDIENT91ZQW5JF1ZCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ChlordiazepoxideACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ClidiniumACTIVE MOIETYBO76JF850NCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C green no. 3INACTIVE INGREDIENT3P3ONR6O1SCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1UCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE) CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSN42b4b9c2-24d7-439b-a90a-f1fcba0a19489
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCD42b4b9c2-24d7-439b-a90a-f1fcba0a19489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76439-302-1076439030210100 CAPSULE in 1 BOTTLE (76439-302-10) 100 capsule2012-06-080000-00-00NoNoCurrent