dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: solaris pharma corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler solaris pharma corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Solaris Pharma Corporation

Identifiers & Regulatory

Product NDC 73473-800
Product ID 73473-800_8aedf1df-44c6-47d1-8a9d-8ce2b757ae12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216639
Listing Expiration 2026-12-31
Marketing Start 2025-06-10

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73473800
Hyphenated Format 73473-800

Supplemental Identifiers

RxCUI
991061
UPC
0373473800102 0373473800010
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 ANDA216639 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (73473-800-01)
  • 1000 CAPSULE in 1 BOTTLE (73473-800-10)
source: ndc

Packages (2)

73473-800-01 100 CAPSULE in 1 BOTTLE (73473-800-01) 73473-800-10 1000 CAPSULE in 1 BOTTLE (73473-800-10)

Ingredients (1)

dicyclomine hydrochloride (10 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": "8aedf1df-44c6-47d1-8a9d-8ce2b757ae12", "openfda": {"upc": ["0373473800102", "0373473800010"], "unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["4237bb2e-d6dd-4e3a-baa2-85be5dc3c8f2"], "manufacturer_name": ["Solaris Pharma Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (73473-800-01)", "package_ndc": "73473-800-01", "marketing_start_date": "20250610"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (73473-800-10)", "package_ndc": "73473-800-10", "marketing_start_date": "20250610"}], "brand_name": "DICYCLOMINE HYDROCHLORIDE", "product_id": "73473-800_8aedf1df-44c6-47d1-8a9d-8ce2b757ae12", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "73473-800", "generic_name": "DICYCLOMINE HYDROCHLORIDE", "labeler_name": "Solaris Pharma Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICYCLOMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA216639", "marketing_category": "ANDA", "marketing_start_date": "20250610", "listing_expiration_date": "20261231"}