dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6053
Product ID 0832-6053_4368e60e-34d6-f0c2-e063-6294a90a1dbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216639
Marketing Start 2023-03-24
Marketing End 2026-09-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326053
Hyphenated Format 0832-6053

Supplemental Identifiers

RxCUI
991061
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
  • 1000 CAPSULE in 1 BOTTLE (0832-6053-10)
  • 100 CAPSULE in 1 BOTTLE (0832-6053-11)
source: ndc

Packages (2)

0832-6053-10 1000 CAPSULE in 1 BOTTLE (0832-6053-10) 0832-6053-11 100 CAPSULE in 1 BOTTLE (0832-6053-11)

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": "4368e60e-34d6-f0c2-e063-6294a90a1dbd", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["c60cb7fd-0ec7-4b6c-a535-34d79b2167b6"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0832-6053-10)", "package_ndc": "0832-6053-10", "marketing_end_date": "20260930", "marketing_start_date": "20230413"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0832-6053-11)", "package_ndc": "0832-6053-11", "marketing_end_date": "20260930", "marketing_start_date": "20230413"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "0832-6053_4368e60e-34d6-f0c2-e063-6294a90a1dbd", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0832-6053", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "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_end_date": "20260930", "marketing_start_date": "20230324"}