dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler bionpharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-311
Product ID 69452-311_1927b1f0-6fee-f127-e063-6394a90a05a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217916
Listing Expiration 2026-12-31
Marketing Start 2023-09-13

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452311
Hyphenated Format 69452-311

Supplemental Identifiers

RxCUI
991086
UNII
CQ903KQA31

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 dicyclomine hydrochloride (source: ndc)
Generic Name dicyclomine hydrochloride (source: ndc)
Application Number ANDA217916 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (69452-311-20)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (69452-311-32)
source: ndc

Packages (2)

69452-311-20 100 TABLET in 1 BOTTLE, PLASTIC (69452-311-20) 69452-311-32 1000 TABLET in 1 BOTTLE, PLASTIC (69452-311-32)

Ingredients (1)

dicyclomine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Dicyclomine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1927b1f0-6fee-f127-e063-6394a90a05a3", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["051bfee3-06cf-309a-e063-6394a90a0bb3"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69452-311-20)", "package_ndc": "69452-311-20", "marketing_start_date": "20230913"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (69452-311-32)", "package_ndc": "69452-311-32", "marketing_start_date": "20240523"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "69452-311_1927b1f0-6fee-f127-e063-6394a90a05a3", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "69452-311", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA217916", "marketing_category": "ANDA", "marketing_start_date": "20230913", "listing_expiration_date": "20261231"}