dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

dicyclomine hydrochloride 20 mg/2mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-1980
Product ID 0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208353
Listing Expiration 2026-12-31
Marketing Start 2017-09-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05171980
Hyphenated Format 0517-1980

Supplemental Identifiers

RxCUI
991065
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 ANDA208353 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 20 mg/2mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)
source: ndc

Packages (2)

0517-1980-05 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01) 0517-1980-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)

Ingredients (1)

dicyclomine hydrochloride (20 mg/2mL)

Linked Drug Pages (1)

Dicyclomine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "9ffbe6bb-e13f-48d4-a8e0-55936b5167dd", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991065"], "spl_set_id": ["cab4ecaf-8895-4ae8-add3-233d9cc570a8"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-05)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)", "package_ndc": "0517-1980-05", "marketing_start_date": "20170911"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0517-1980-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-1980-01)", "package_ndc": "0517-1980-10", "marketing_start_date": "20170911"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "0517-1980_9ffbe6bb-e13f-48d4-a8e0-55936b5167dd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0517-1980", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/2mL"}], "application_number": "ANDA208353", "marketing_category": "ANDA", "marketing_start_date": "20170901", "listing_expiration_date": "20261231"}