dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6987
Product ID 0904-6987_5d042b74-77b3-401e-b019-4807df743055
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084285
Listing Expiration 2026-12-31
Marketing Start 1999-02-26

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046987
Hyphenated Format 0904-6987

Supplemental Identifiers

RxCUI
991061 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 ANDA084285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6987-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

dicyclomine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5d042b74-77b3-401e-b019-4807df743055", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061", "991086"], "spl_set_id": ["5eee0dff-d157-4534-adfb-c035b7042c07"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6987-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6987-61", "marketing_start_date": "19990226"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "0904-6987_5d042b74-77b3-401e-b019-4807df743055", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0904-6987", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "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": "19990226", "listing_expiration_date": "20261231"}