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 72789-522
Product ID 72789-522_4b30ce9b-4170-edc0-e063-6394a90a11d8
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 72789522
Hyphenated Format 72789-522

Supplemental Identifiers

RxCUI
991061
UPC
0372789522951
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
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-01)
  • 28 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-28)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-90)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-93)
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-95)
  • 120 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-98)
source: ndc

Packages (7)

72789-522-01 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-01) 72789-522-28 28 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-28) 72789-522-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-30) 72789-522-90 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-90) 72789-522-93 180 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-93) 72789-522-95 1000 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-95) 72789-522-98 120 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-98)

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": "4b30ce9b-4170-edc0-e063-6394a90a11d8", "openfda": {"upc": ["0372789522951"], "unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["400ac94f-2cf6-bd52-e063-6294a90a4f05"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-01)", "package_ndc": "72789-522-01", "marketing_start_date": "20250930"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-28)", "package_ndc": "72789-522-28", "marketing_start_date": "20260107"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-30)", "package_ndc": "72789-522-30", "marketing_start_date": "20260219"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-90)", "package_ndc": "72789-522-90", "marketing_start_date": "20250930"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-93)", "package_ndc": "72789-522-93", "marketing_start_date": "20250930"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-95)", "package_ndc": "72789-522-95", "marketing_start_date": "20250930"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE, PLASTIC (72789-522-98)", "package_ndc": "72789-522-98", "marketing_start_date": "20250930"}], "brand_name": "DICYCLOMINE HYDROCHLORIDE", "product_id": "72789-522_4b30ce9b-4170-edc0-e063-6394a90a11d8", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "72789-522", "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"}