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 TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-259
Product ID 16571-259_c68c26a1-6f4c-4853-9e9d-1e2e2e3d5a6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218952
Listing Expiration 2027-12-31
Marketing Start 2024-11-15

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571259
Hyphenated Format 16571-259

Supplemental Identifiers

RxCUI
991086
UPC
0316571259014
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 ANDA218952 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-259-01)
  • 1000 TABLET in 1 BOTTLE (16571-259-10)
source: ndc

Packages (2)

16571-259-01 100 TABLET in 1 BOTTLE (16571-259-01) 16571-259-10 1000 TABLET in 1 BOTTLE (16571-259-10)

Ingredients (1)

dicyclomine hydrochloride (20 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": "c68c26a1-6f4c-4853-9e9d-1e2e2e3d5a6c", "openfda": {"upc": ["0316571259014"], "unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["0a97e9c8-7046-4b92-93ad-dd9e01ce0fc4"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-259-01)", "package_ndc": "16571-259-01", "marketing_start_date": "20241115"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16571-259-10)", "package_ndc": "16571-259-10", "marketing_start_date": "20241115"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "16571-259_c68c26a1-6f4c-4853-9e9d-1e2e2e3d5a6c", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "16571-259", "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": "20 mg/1"}], "application_number": "ANDA218952", "marketing_category": "ANDA", "marketing_start_date": "20241115", "listing_expiration_date": "20271231"}