dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-260
Product ID 16571-260_239ecf22-4237-4f27-b17c-6fddabcc9d9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219242
Listing Expiration 2027-12-31
Marketing Start 2025-06-23

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571260
Hyphenated Format 16571-260

Supplemental Identifiers

RxCUI
991061
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 ANDA219242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (16571-260-01)
  • 1000 CAPSULE in 1 BOTTLE (16571-260-10)
source: ndc

Packages (2)

16571-260-01 100 CAPSULE in 1 BOTTLE (16571-260-01) 16571-260-10 1000 CAPSULE in 1 BOTTLE (16571-260-10)

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": "239ecf22-4237-4f27-b17c-6fddabcc9d9d", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["029baf6d-4e85-48fd-9efc-158fe0f629bb"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16571-260-01)", "package_ndc": "16571-260-01", "marketing_start_date": "20250623"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (16571-260-10)", "package_ndc": "16571-260-10", "marketing_start_date": "20250623"}], "brand_name": "DICYCLOMINE HYDROCHLORIDE", "product_id": "16571-260_239ecf22-4237-4f27-b17c-6fddabcc9d9d", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "16571-260", "generic_name": "DICYCLOMINE HYDROCHLORIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DICYCLOMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA219242", "marketing_category": "ANDA", "marketing_start_date": "20250623", "listing_expiration_date": "20271231"}