dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler coupler llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1513
Product ID 67046-1513_2d439d2b-8c63-3c15-e063-6394a90a39be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217531
Listing Expiration 2026-12-31
Marketing Start 2025-02-03

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461513
Hyphenated Format 67046-1513

Supplemental Identifiers

RxCUI
991061
UNII
CQ903KQA31

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 ANDA217531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (67046-1513-3)
source: ndc

Packages (1)

67046-1513-3 30 CAPSULE in 1 BLISTER PACK (67046-1513-3)

Ingredients (1)

dicyclomine hydrochloride (10 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": "2d439d2b-8c63-3c15-e063-6394a90a39be", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["2d439669-5cbc-292f-e063-6394a90a7ca9"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1513-3)", "package_ndc": "67046-1513-3", "marketing_start_date": "20250203"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "67046-1513_2d439d2b-8c63-3c15-e063-6394a90a39be", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "67046-1513", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA217531", "marketing_category": "ANDA", "marketing_start_date": "20250203", "listing_expiration_date": "20261231"}