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 SOLUTION
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0622
Product ID 0054-0622_8ad8c412-22d6-424f-9a52-48074ab28d4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212286
Listing Expiration 2026-12-31
Marketing Start 2020-05-22

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540622
Hyphenated Format 0054-0622

Supplemental Identifiers

RxCUI
991082
UPC
0300540622633
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 ANDA212286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0054-0622-63)
source: ndc

Packages (1)

0054-0622-63 473 mL in 1 BOTTLE (0054-0622-63)

Ingredients (1)

dicyclomine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Dicyclomine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8ad8c412-22d6-424f-9a52-48074ab28d4f", "openfda": {"upc": ["0300540622633"], "unii": ["CQ903KQA31"], "rxcui": ["991082"], "spl_set_id": ["aa5bd79d-7f18-4032-8862-0c5429b2ecaf"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0054-0622-63)", "package_ndc": "0054-0622-63", "marketing_start_date": "20200522"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "0054-0622_8ad8c412-22d6-424f-9a52-48074ab28d4f", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0054-0622", "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/5mL"}], "application_number": "ANDA212286", "marketing_category": "ANDA", "marketing_start_date": "20200522", "listing_expiration_date": "20261231"}