dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

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

Drug Facts

Product Profile

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

dicyclomine hydrochloride 10 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0748
Product ID 0054-0748_99d7d1ce-47b5-4bbd-afe0-908505a9a51b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040204
Listing Expiration 2026-12-31
Marketing Start 1997-02-28

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540748
Hyphenated Format 0054-0748

Supplemental Identifiers

RxCUI
991061
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 ANDA040204 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-25)
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-31)
source: ndc

Packages (2)

0054-0748-25 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-25) 0054-0748-31 1000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-31)

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": "99d7d1ce-47b5-4bbd-afe0-908505a9a51b", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["99d7d1ce-47b5-4bbd-afe0-908505a9a51b"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-25)", "package_ndc": "0054-0748-25", "marketing_start_date": "20230605"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-31)", "package_ndc": "0054-0748-31", "marketing_start_date": "20230605"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "0054-0748_99d7d1ce-47b5-4bbd-afe0-908505a9a51b", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0054-0748", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA040204", "marketing_category": "ANDA", "marketing_start_date": "19970228", "listing_expiration_date": "20261231"}