dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: trifluent pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler trifluent pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 40 mg/1

Manufacturer
Trifluent Pharma, LLC

Identifiers & Regulatory

Product NDC 73352-119
Product ID 73352-119_4008fdd6-a9b7-b299-e063-6394a90afdfd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216736
Listing Expiration 2026-12-31
Marketing Start 2025-07-14

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73352119
Hyphenated Format 73352-119

Supplemental Identifiers

RxCUI
2719470
UPC
0373352119608
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 ANDA216736 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (73352-119-60)
source: ndc

Packages (1)

73352-119-60 60 TABLET in 1 BOTTLE (73352-119-60)

Ingredients (1)

dicyclomine hydrochloride (40 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": "4008fdd6-a9b7-b299-e063-6394a90afdfd", "openfda": {"upc": ["0373352119608"], "unii": ["CQ903KQA31"], "rxcui": ["2719470"], "spl_set_id": ["56282794-5874-4220-b25c-cea4b17d19aa"], "manufacturer_name": ["Trifluent Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (73352-119-60)", "package_ndc": "73352-119-60", "marketing_start_date": "20250714"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "73352-119_4008fdd6-a9b7-b299-e063-6394a90afdfd", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "73352-119", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Trifluent Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA216736", "marketing_category": "ANDA", "marketing_start_date": "20250714", "listing_expiration_date": "20261231"}