dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: solco healthcare us,llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler solco healthcare us,llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Solco Healthcare US,LLC

Identifiers & Regulatory

Product NDC 43547-634
Product ID 43547-634_d0954a7a-812b-487e-8c22-2a2a58303277
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217531
Listing Expiration 2026-12-31
Marketing Start 2022-08-23

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547634
Hyphenated Format 43547-634

Supplemental Identifiers

RxCUI
991061
UPC
0343547634100
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 ANDA217531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (43547-634-10)
  • 1000 CAPSULE in 1 BOTTLE (43547-634-11)
  • 500 CAPSULE in 1 BOTTLE (43547-634-50)
source: ndc

Packages (3)

43547-634-10 100 CAPSULE in 1 BOTTLE (43547-634-10) 43547-634-11 1000 CAPSULE in 1 BOTTLE (43547-634-11) 43547-634-50 500 CAPSULE in 1 BOTTLE (43547-634-50)

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": "d0954a7a-812b-487e-8c22-2a2a58303277", "openfda": {"upc": ["0343547634100"], "unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["d0954a7a-812b-487e-8c22-2a2a58303277"], "manufacturer_name": ["Solco Healthcare US,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (43547-634-10)", "package_ndc": "43547-634-10", "marketing_start_date": "20220823"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (43547-634-11)", "package_ndc": "43547-634-11", "marketing_start_date": "20220823"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (43547-634-50)", "package_ndc": "43547-634-50", "marketing_start_date": "20220823"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "43547-634_d0954a7a-812b-487e-8c22-2a2a58303277", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "43547-634", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Solco Healthcare US,LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA217531", "marketing_category": "ANDA", "marketing_start_date": "20220823", "listing_expiration_date": "20261231"}