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 CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-546
Product ID 72789-546_47e64690-d756-1ea9-e063-6394a90a1499
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216639
Listing Expiration 2027-12-31
Marketing Start 2025-09-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789546
Hyphenated Format 72789-546

Supplemental Identifiers

RxCUI
991061
UPC
0372789546285
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 ANDA216639 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (72789-546-28)
source: ndc

Packages (1)

72789-546-28 28 CAPSULE in 1 BOTTLE, PLASTIC (72789-546-28)

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": "47e64690-d756-1ea9-e063-6394a90a1499", "openfda": {"upc": ["0372789546285"], "unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["dd3a8428-f71f-4f39-91c9-328d2a30eeba"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (72789-546-28)", "package_ndc": "72789-546-28", "marketing_start_date": "20260108"}], "brand_name": "DICYCLOMINE HYDROCHLORIDE", "product_id": "72789-546_47e64690-d756-1ea9-e063-6394a90a1499", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "72789-546", "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": "10 mg/1"}], "application_number": "ANDA216639", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20271231"}