dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler endo usa, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/5mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0603-1161
Product ID 0603-1161_5f04cd24-b303-43dc-a963-f28d35a275ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040169
Listing Expiration 2026-12-31
Marketing Start 2005-06-23

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06031161
Hyphenated Format 0603-1161

Supplemental Identifiers

RxCUI
991082
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 ANDA040169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (0603-1161-58)
source: ndc

Packages (1)

0603-1161-58 473 mL in 1 BOTTLE, PLASTIC (0603-1161-58)

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": "5f04cd24-b303-43dc-a963-f28d35a275ff", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991082"], "spl_set_id": ["bb099db9-f635-4a64-8892-6236971dec45"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0603-1161-58)", "package_ndc": "0603-1161-58", "marketing_start_date": "20050623"}], "brand_name": "dicyclomine hydrochloride", "product_id": "0603-1161_5f04cd24-b303-43dc-a963-f28d35a275ff", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0603-1161", "generic_name": "dicyclomine hydrochloride", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA040169", "marketing_category": "ANDA", "marketing_start_date": "20050623", "listing_expiration_date": "20261231"}