chlordiazepoxide hydrochloride and clidinium bromide

Generic: chlordiazepoxide hydrochloride and clidinium bromide

Labeler: ascend laboratories, llc
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 ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-731
Product ID 67877-731_541259c3-7b51-4c46-a11c-f199d185ace0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214065
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-04-27

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 67877731
Hyphenated Format 67877-731

Supplemental Identifiers

RxCUI
889614
UPC
0367877731018
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 ANDA214065 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (67877-731-01)
  • 500 CAPSULE in 1 BOTTLE (67877-731-05)
  • 100 BLISTER PACK in 1 CARTON (67877-731-38) / 10 CAPSULE in 1 BLISTER PACK (67877-731-33)
source: ndc

Packages (3)

67877-731-01 100 CAPSULE in 1 BOTTLE (67877-731-01) 67877-731-05 500 CAPSULE in 1 BOTTLE (67877-731-05) 67877-731-38 100 BLISTER PACK in 1 CARTON (67877-731-38) / 10 CAPSULE in 1 BLISTER PACK (67877-731-33)

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": "541259c3-7b51-4c46-a11c-f199d185ace0", "openfda": {"upc": ["0367877731018"], "unii": ["MFM6K1XWDK", "91ZQW5JF1Z"], "rxcui": ["889614"], "spl_set_id": ["19fdde81-e0f2-4269-bd57-252a759b7593"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (67877-731-01)", "package_ndc": "67877-731-01", "marketing_start_date": "20210427"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (67877-731-05)", "package_ndc": "67877-731-05", "marketing_start_date": "20210427"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (67877-731-38)  / 10 CAPSULE in 1 BLISTER PACK (67877-731-33)", "package_ndc": "67877-731-38", "marketing_start_date": "20210427"}], "brand_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide", "product_id": "67877-731_541259c3-7b51-4c46-a11c-f199d185ace0", "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": "67877-731", "dea_schedule": "CIV", "generic_name": "Chlordiazepoxide Hydrochloride and Clidinium Bromide", "labeler_name": "Ascend Laboratories, LLC", "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": "ANDA214065", "marketing_category": "ANDA", "marketing_start_date": "20210427", "listing_expiration_date": "20261231"}