FDA.reportPublic FDA data

Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC
11534-197
11-digit product format
115340197
Labeler code
11534
Product ID
11534-197_3ecf4af2-f5a1-43f1-ac8b-bf88037950d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Sunrise Pharmaceutical, Inc.
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE5 mg/1
CLIDINIUM BROMIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMFM6K1XWDK, 91ZQW5JF1Z
Rxcui889614

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
632cace7-5e66-44d3-b8c3-9d6af8cdd96aProduct name520250623
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11534-197-01Chlordiazepoxide Hydrochloride and Clidinium Bromide100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-197-01EA - Each11534-197caf2e50e-66d4-483f-93bc-56c9bc5cd50712020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-197CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [SUNRISE PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 1 package rows20220811_3cce1912-e7c8-4f30-bd76-dfa4b9d65bac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNc3223f35-1baf-46bf-9eb3-55455f672d85104
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDc3223f35-1baf-46bf-9eb3-55455f672d85104
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSN160c6524-314f-404a-ac04-0f3bfae2fde3101
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCD160c6524-314f-404a-ac04-0f3bfae2fde3101
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSN68d8dca6-697d-401e-acaf-01bfe4c4da17100
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNd4ed59f7-7624-480f-b151-2d4e9b6b7013100
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCD68d8dca6-697d-401e-acaf-01bfe4c4da17100
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDd4ed59f7-7624-480f-b151-2d4e9b6b7013100
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSN3cce1912-e7c8-4f30-bd76-dfa4b9d65bac7
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCD3cce1912-e7c8-4f30-bd76-dfa4b9d65bac7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-197-0111534019701100 CAPSULE in 1 BOTTLE (11534-197-01) 100 capsule2020-07-090000-00-00NoNoCurrent