dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dicyclomine hydrochloride 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-466
Product ID 72789-466_47ba6123-eefb-87a2-e063-6394a90a5f13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216736
Listing Expiration 2027-12-31
Marketing Start 2022-12-14

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789466
Hyphenated Format 72789-466

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 ANDA216736 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-466-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-466-30)
  • 500 TABLET in 1 BOTTLE, PLASTIC (72789-466-82)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-466-90)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (72789-466-95)
source: ndc

Packages (5)

72789-466-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-466-01) 72789-466-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-466-30) 72789-466-82 500 TABLET in 1 BOTTLE, PLASTIC (72789-466-82) 72789-466-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-466-90) 72789-466-95 1000 TABLET in 1 BOTTLE, PLASTIC (72789-466-95)

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": "47ba6123-eefb-87a2-e063-6394a90a5f13", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["c0a6db32-1061-4721-b5ea-0082ff41acbf"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-466-01)", "package_ndc": "72789-466-01", "marketing_start_date": "20241227"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-466-30)", "package_ndc": "72789-466-30", "marketing_start_date": "20250728"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (72789-466-82)", "package_ndc": "72789-466-82", "marketing_start_date": "20241227"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-466-90)", "package_ndc": "72789-466-90", "marketing_start_date": "20250903"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-466-95)", "package_ndc": "72789-466-95", "marketing_start_date": "20241227"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "72789-466_47ba6123-eefb-87a2-e063-6394a90a5f13", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "72789-466", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA216736", "marketing_category": "ANDA", "marketing_start_date": "20221214", "listing_expiration_date": "20271231"}