chlordiazepoxide hydrochloride and clidinium bromide

Generic: chlordiazepoxide hydrochloride and clidinium bromide

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlordiazepoxide hydrochloride and clidinium bromide
Generic Name chlordiazepoxide hydrochloride and clidinium bromide
Labeler sunrise pharmaceutical, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

chlordiazepoxide hydrochloride 5 mg/1, clidinium bromide 2.5 mg/1

Manufacturer
Sunrise Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11534-197
Product ID 11534-197_3ecf4af2-f5a1-43f1-ac8b-bf88037950d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211421
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-07-09

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11534197
Hyphenated Format 11534-197

Supplemental Identifiers

RxCUI
889614
UPC
0311534197013
UNII
MFM6K1XWDK 91ZQW5JF1Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name chlordiazepoxide hydrochloride and clidinium bromide (source: ndc)
Generic Name chlordiazepoxide hydrochloride and clidinium bromide (source: ndc)
Application Number ANDA211421 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (11534-197-01)
source: ndc

Packages (1)

11534-197-01 100 CAPSULE in 1 BOTTLE (11534-197-01)

Ingredients (2)

chlordiazepoxide hydrochloride (5 mg/1) clidinium bromide (2.5 mg/1)

Linked Drug Pages (1)

Chlordiazepoxide Hydrochloride and Clidinium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ecf4af2-f5a1-43f1-ac8b-bf88037950d5", "openfda": {"upc": ["0311534197013"], "unii": ["MFM6K1XWDK", "91ZQW5JF1Z"], "rxcui": ["889614"], "spl_set_id": ["3cce1912-e7c8-4f30-bd76-dfa4b9d65bac"], "manufacturer_name": ["Sunrise Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (11534-197-01)", "package_ndc": "11534-197-01", "marketing_start_date": "20200709"}], "brand_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide", "product_id": "11534-197_3ecf4af2-f5a1-43f1-ac8b-bf88037950d5", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cholinergic Antagonists [MoA]", "Decreased Parasympathetic Acetylcholine Activity [PE]", "Digestive/GI System Activity Alteration [PE]", "GI Motility Alteration [PE]"], "product_ndc": "11534-197", "dea_schedule": "CIV", "generic_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide", "labeler_name": "Sunrise Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlordiazepoxide Hydrochloride and Clidinium Bromide", "active_ingredients": [{"name": "CHLORDIAZEPOXIDE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "CLIDINIUM BROMIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA211421", "marketing_category": "ANDA", "marketing_start_date": "20200709", "listing_expiration_date": "20261231"}