chlordiazepoxide hydrochloride and clidinium bromide

Generic: chlordiazepoxide hydrochloride and clidinium bromide

Labeler: alembic pharmaceuticals limited
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 alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-744
Product ID 46708-744_398931c6-4954-4bbc-8b63-ea382e5864fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216969
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-10-04

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 46708744
Hyphenated Format 46708-744

Supplemental Identifiers

RxCUI
889614
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 ANDA216969 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (46708-744-31)
  • 1000 CAPSULE in 1 BOTTLE (46708-744-91)
source: ndc

Packages (2)

46708-744-31 100 CAPSULE in 1 BOTTLE (46708-744-31) 46708-744-91 1000 CAPSULE in 1 BOTTLE (46708-744-91)

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": "398931c6-4954-4bbc-8b63-ea382e5864fc", "openfda": {"unii": ["MFM6K1XWDK", "91ZQW5JF1Z"], "rxcui": ["889614"], "spl_set_id": ["398931c6-4954-4bbc-8b63-ea382e5864fc"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-744-31)", "package_ndc": "46708-744-31", "marketing_start_date": "20231004"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-744-91)", "package_ndc": "46708-744-91", "marketing_start_date": "20231004"}], "brand_name": "Chlordiazepoxide hydrochloride and clidinium bromide", "product_id": "46708-744_398931c6-4954-4bbc-8b63-ea382e5864fc", "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": "46708-744", "dea_schedule": "CIV", "generic_name": "Chlordiazepoxide hydrochloride and clidinium bromide", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "ANDA216969", "marketing_category": "ANDA", "marketing_start_date": "20231004", "listing_expiration_date": "20261231"}