dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler lannett company, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-0586
Product ID 0527-0586_2d14aa91-5d9d-42fe-b185-9c3bcd18a513
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084285
Listing Expiration 2026-12-31
Marketing Start 1974-09-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05270586
Hyphenated Format 0527-0586

Supplemental Identifiers

RxCUI
991061 991086
UPC
0305270586019
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 ANDA084285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0527-0586-01)
  • 500 CAPSULE in 1 BOTTLE (0527-0586-05)
  • 1000 CAPSULE in 1 BOTTLE (0527-0586-10)
source: ndc

Packages (3)

0527-0586-01 100 CAPSULE in 1 BOTTLE (0527-0586-01) 0527-0586-05 500 CAPSULE in 1 BOTTLE (0527-0586-05) 0527-0586-10 1000 CAPSULE in 1 BOTTLE (0527-0586-10)

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": "2d14aa91-5d9d-42fe-b185-9c3bcd18a513", "openfda": {"upc": ["0305270586019"], "unii": ["CQ903KQA31"], "rxcui": ["991061", "991086"], "spl_set_id": ["bd2cba10-70ec-4d1f-b46c-53d1de2ee130"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0527-0586-01)", "package_ndc": "0527-0586-01", "marketing_start_date": "19740930"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0527-0586-05)", "package_ndc": "0527-0586-05", "marketing_start_date": "19740930"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0527-0586-10)", "package_ndc": "0527-0586-10", "marketing_start_date": "19740930"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "0527-0586_2d14aa91-5d9d-42fe-b185-9c3bcd18a513", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0527-0586", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA084285", "marketing_category": "ANDA", "marketing_start_date": "19740930", "listing_expiration_date": "20261231"}