dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

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

Drug Facts

Product Profile

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

dicyclomine hydrochloride 20 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8540
Product ID 68788-8540_6f6b79ee-4fad-42cd-8e5b-5c134e62793d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216782
Listing Expiration 2026-12-31
Marketing Start 2023-11-10

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888540
Hyphenated Format 68788-8540

Supplemental Identifiers

RxCUI
991086
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 ANDA216782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (68788-8540-2)
  • 30 TABLET in 1 BOTTLE, PLASTIC (68788-8540-3)
  • 60 TABLET in 1 BOTTLE, PLASTIC (68788-8540-6)
  • 90 TABLET in 1 BOTTLE, PLASTIC (68788-8540-9)
source: ndc

Packages (4)

68788-8540-2 20 TABLET in 1 BOTTLE, PLASTIC (68788-8540-2) 68788-8540-3 30 TABLET in 1 BOTTLE, PLASTIC (68788-8540-3) 68788-8540-6 60 TABLET in 1 BOTTLE, PLASTIC (68788-8540-6) 68788-8540-9 90 TABLET in 1 BOTTLE, PLASTIC (68788-8540-9)

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": "6f6b79ee-4fad-42cd-8e5b-5c134e62793d", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["516031cf-97ee-4838-90ef-a43dedd2f598"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (68788-8540-2)", "package_ndc": "68788-8540-2", "marketing_start_date": "20231110"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (68788-8540-3)", "package_ndc": "68788-8540-3", "marketing_start_date": "20231110"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (68788-8540-6)", "package_ndc": "68788-8540-6", "marketing_start_date": "20231110"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (68788-8540-9)", "package_ndc": "68788-8540-9", "marketing_start_date": "20231110"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "68788-8540_6f6b79ee-4fad-42cd-8e5b-5c134e62793d", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "68788-8540", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA216782", "marketing_category": "ANDA", "marketing_start_date": "20231110", "listing_expiration_date": "20261231"}