dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

dicyclomine hydrochloride 10 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-431
Product ID 70069-431_a927b130-5b1b-462f-bb0c-2ea8763487ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214332
Listing Expiration 2026-12-31
Marketing Start 2024-11-05

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069431
Hyphenated Format 70069-431

Supplemental Identifiers

RxCUI
991065
UPC
0370069431054 0370069441053 0370069431016 0370069441015
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 ANDA214332 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (70069-431-05) / 2 mL in 1 VIAL (70069-431-01)
source: ndc

Packages (1)

70069-431-05 5 VIAL in 1 CARTON (70069-431-05) / 2 mL in 1 VIAL (70069-431-01)

Ingredients (1)

dicyclomine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

DICYCLOMINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "a927b130-5b1b-462f-bb0c-2ea8763487ee", "openfda": {"upc": ["0370069431054", "0370069441053", "0370069431016", "0370069441015"], "unii": ["CQ903KQA31"], "rxcui": ["991065"], "spl_set_id": ["7ad77f59-e24a-406d-95bf-3d5c6cbc3cbe"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (70069-431-05)  / 2 mL in 1 VIAL (70069-431-01)", "package_ndc": "70069-431-05", "marketing_start_date": "20241105"}], "brand_name": "DICYCLOMINE HYDROCHLORIDE", "product_id": "70069-431_a927b130-5b1b-462f-bb0c-2ea8763487ee", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "70069-431", "generic_name": "DICYCLOMINE HYDROCHLORIDE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICYCLOMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA214332", "marketing_category": "ANDA", "marketing_start_date": "20241105", "listing_expiration_date": "20261231"}