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 CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8578
Product ID 68788-8578_eab30315-f199-40ea-a2f2-a70d138c2c60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040319
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888578
Hyphenated Format 68788-8578

Supplemental Identifiers

RxCUI
991061
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 ANDA040319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8578-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8578-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8578-6)
  • 90 CAPSULE in 1 BOTTLE (68788-8578-9)
source: ndc

Packages (4)

68788-8578-1 100 CAPSULE in 1 BOTTLE (68788-8578-1) 68788-8578-3 30 CAPSULE in 1 BOTTLE (68788-8578-3) 68788-8578-6 60 CAPSULE in 1 BOTTLE (68788-8578-6) 68788-8578-9 90 CAPSULE in 1 BOTTLE (68788-8578-9)

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": "eab30315-f199-40ea-a2f2-a70d138c2c60", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["a5864c57-d73c-45c6-8985-7a041c84ccad"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8578-1)", "package_ndc": "68788-8578-1", "marketing_start_date": "20241206"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8578-3)", "package_ndc": "68788-8578-3", "marketing_start_date": "20240201"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8578-6)", "package_ndc": "68788-8578-6", "marketing_start_date": "20241206"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8578-9)", "package_ndc": "68788-8578-9", "marketing_start_date": "20241206"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "68788-8578_eab30315-f199-40ea-a2f2-a70d138c2c60", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "68788-8578", "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": "10 mg/1"}], "application_number": "ANDA040319", "marketing_category": "ANDA", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}