dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dicyclomine hydrochloride 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-199
Product ID 50268-199_47e343c9-2e61-c288-e063-6394a90a0b5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217054
Listing Expiration 2027-12-31
Marketing Start 2024-03-20

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268199
Hyphenated Format 50268-199

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 ANDA217054 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-199-15) / 1 CAPSULE in 1 BLISTER PACK (50268-199-11)
source: ndc

Packages (1)

50268-199-15 50 BLISTER PACK in 1 BOX (50268-199-15) / 1 CAPSULE in 1 BLISTER PACK (50268-199-11)

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": "47e343c9-2e61-c288-e063-6394a90a0b5c", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["141d3818-7a87-aaa0-e063-6294a90a4866"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-199-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-199-11)", "package_ndc": "50268-199-15", "marketing_start_date": "20240320"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "50268-199_47e343c9-2e61-c288-e063-6394a90a0b5c", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "50268-199", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA217054", "marketing_category": "ANDA", "marketing_start_date": "20240320", "listing_expiration_date": "20271231"}