dicyclomine

Generic: dicyclomine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine
Generic Name dicyclomine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-1227
Product ID 0143-1227_ab1abd30-25fd-46ed-a992-925836112c98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040161
Listing Expiration 2026-12-31
Marketing Start 1996-10-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01431227
Hyphenated Format 0143-1227

Supplemental Identifiers

RxCUI
991086
UPC
0301431227012
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 (source: ndc)
Generic Name dicyclomine hydrochloride (source: ndc)
Application Number ANDA040161 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0143-1227-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1227-10)
source: ndc

Packages (2)

0143-1227-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1227-01) 0143-1227-10 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1227-10)

Ingredients (1)

dicyclomine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Dicyclomine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ab1abd30-25fd-46ed-a992-925836112c98", "openfda": {"upc": ["0301431227012"], "unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["5a553bda-1e3d-4b80-913f-73dd54655033"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0143-1227-01)", "package_ndc": "0143-1227-01", "marketing_start_date": "19961001"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0143-1227-10)", "package_ndc": "0143-1227-10", "marketing_start_date": "19961001"}], "brand_name": "Dicyclomine", "product_id": "0143-1227_ab1abd30-25fd-46ed-a992-925836112c98", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0143-1227", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA040161", "marketing_category": "ANDA", "marketing_start_date": "19961001", "listing_expiration_date": "20261231"}