dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: advagen pharma ltd.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler advagen pharma ltd.,
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 40 mg/1

Manufacturer
Advagen Pharma Ltd.,

Identifiers & Regulatory

Product NDC 72888-198
Product ID 72888-198_4b7e07c5-f687-74a5-e063-6294a90aa7ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216736
Listing Expiration 2027-12-31
Marketing Start 2025-03-25

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888198
Hyphenated Format 72888-198

Supplemental Identifiers

RxCUI
991086 2719470
UPC
0372888198309 0372888119014 0372888198002 0372888198057 0372888198125 0372888119304 0372888119007 0372888119052 0372888198019
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 ANDA216736 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (72888-198-00)
  • 100 TABLET in 1 BOTTLE (72888-198-01)
  • 500 TABLET in 1 BOTTLE (72888-198-05)
  • 120 TABLET in 1 BOTTLE (72888-198-12)
  • 30 TABLET in 1 BOTTLE (72888-198-30)
source: ndc

Packages (5)

72888-198-00 1000 TABLET in 1 BOTTLE (72888-198-00) 72888-198-01 100 TABLET in 1 BOTTLE (72888-198-01) 72888-198-05 500 TABLET in 1 BOTTLE (72888-198-05) 72888-198-12 120 TABLET in 1 BOTTLE (72888-198-12) 72888-198-30 30 TABLET in 1 BOTTLE (72888-198-30)

Ingredients (1)

dicyclomine hydrochloride (40 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": "4b7e07c5-f687-74a5-e063-6294a90aa7ef", "openfda": {"upc": ["0372888198309", "0372888119014", "0372888198002", "0372888198057", "0372888198125", "0372888119304", "0372888119007", "0372888119052", "0372888198019"], "unii": ["CQ903KQA31"], "rxcui": ["991086", "2719470"], "spl_set_id": ["b4331e24-58af-45fb-a25b-9eb8270f83f7"], "manufacturer_name": ["Advagen Pharma Ltd.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-198-00)", "package_ndc": "72888-198-00", "marketing_start_date": "20250325"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-198-01)", "package_ndc": "72888-198-01", "marketing_start_date": "20250325"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-198-05)", "package_ndc": "72888-198-05", "marketing_start_date": "20250325"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72888-198-12)", "package_ndc": "72888-198-12", "marketing_start_date": "20250325"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72888-198-30)", "package_ndc": "72888-198-30", "marketing_start_date": "20260217"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "72888-198_4b7e07c5-f687-74a5-e063-6294a90aa7ef", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "72888-198", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Advagen Pharma Ltd.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA216736", "marketing_category": "ANDA", "marketing_start_date": "20250325", "listing_expiration_date": "20271231"}