dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-923
Product ID 55289-923_2ac0893d-8730-c60f-e063-6394a90a3c88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085082
Listing Expiration 2026-12-31
Marketing Start 1986-06-19

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289923
Hyphenated Format 55289-923

Supplemental Identifiers

RxCUI
991061
UPC
0355289923206
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 ANDA085082 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-20)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-28)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-30)
source: ndc

Packages (3)

55289-923-20 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-20) 55289-923-28 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-28) 55289-923-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-30)

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": "2ac0893d-8730-c60f-e063-6394a90a3c88", "openfda": {"upc": ["0355289923206"], "unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["b3d591ad-4eb7-4cdf-93b2-62cd479e921b"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-20)", "package_ndc": "55289-923-20", "marketing_start_date": "20170622"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-28)", "package_ndc": "55289-923-28", "marketing_start_date": "20151009"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-30)", "package_ndc": "55289-923-30", "marketing_start_date": "20151009"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "55289-923_2ac0893d-8730-c60f-e063-6394a90a3c88", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "55289-923", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA085082", "marketing_category": "ANDA", "marketing_start_date": "19860619", "listing_expiration_date": "20261231"}