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 43063-045
Product ID 43063-045_2b247a51-9783-e240-e063-6294a90a8907
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085223
Listing Expiration 2026-12-31
Marketing Start 1986-07-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063045
Hyphenated Format 43063-045

Supplemental Identifiers

RxCUI
991086
UPC
0343063045206
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 ANDA085223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04)
  • 6 TABLET in 1 BOTTLE, PLASTIC (43063-045-06)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-045-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-045-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-045-60)
source: ndc

Packages (5)

43063-045-04 4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04) 43063-045-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-045-06) 43063-045-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-045-20) 43063-045-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-045-30) 43063-045-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-045-60)

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": "2b247a51-9783-e240-e063-6294a90a8907", "openfda": {"upc": ["0343063045206"], "unii": ["CQ903KQA31"], "rxcui": ["991086"], "spl_set_id": ["da0e1f63-cb90-4c2a-908f-7d81e672be10"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04)", "package_ndc": "43063-045-04", "marketing_start_date": "20081222"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (43063-045-06)", "package_ndc": "43063-045-06", "marketing_start_date": "20130917"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-045-20)", "package_ndc": "43063-045-20", "marketing_start_date": "20130917"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-045-30)", "package_ndc": "43063-045-30", "marketing_start_date": "20130807"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-045-60)", "package_ndc": "43063-045-60", "marketing_start_date": "20140414"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "43063-045_2b247a51-9783-e240-e063-6294a90a8907", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "43063-045", "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": "ANDA085223", "marketing_category": "ANDA", "marketing_start_date": "19860730", "listing_expiration_date": "20261231"}