dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3916
Product ID 68071-3916_43e30b73-4779-d722-e063-6394a90a51de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217566
Listing Expiration 2026-12-31
Marketing Start 2024-05-07

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713916
Hyphenated Format 68071-3916

Supplemental Identifiers

RxCUI
991086
UPC
0368071391664
UNII
CQ903KQA31

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 ANDA217566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE (68071-3916-6)
source: ndc

Packages (1)

68071-3916-6 6 TABLET in 1 BOTTLE (68071-3916-6)

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": "43e30b73-4779-d722-e063-6394a90a51de", "openfda": {"upc": ["0368071391664"], "unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["43e30378-6376-caab-e063-6294a90a8696"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (68071-3916-6)", "package_ndc": "68071-3916-6", "marketing_start_date": "20251118"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "68071-3916_43e30b73-4779-d722-e063-6394a90a51de", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "68071-3916", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA217566", "marketing_category": "ANDA", "marketing_start_date": "20240507", "listing_expiration_date": "20261231"}