dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-052
Product ID 31722-052_1e764ead-f2ea-f00c-e063-6294a90ae86b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218018
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722052
Hyphenated Format 31722-052

Supplemental Identifiers

RxCUI
991061
UPC
0331722052054 0331722052016
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 ANDA218018 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (31722-052-01)
  • 500 CAPSULE in 1 BOTTLE (31722-052-05)
  • 1000 CAPSULE in 1 BOTTLE (31722-052-10)
source: ndc

Packages (3)

31722-052-01 100 CAPSULE in 1 BOTTLE (31722-052-01) 31722-052-05 500 CAPSULE in 1 BOTTLE (31722-052-05) 31722-052-10 1000 CAPSULE in 1 BOTTLE (31722-052-10)

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": "1e764ead-f2ea-f00c-e063-6294a90ae86b", "openfda": {"upc": ["0331722052054", "0331722052016"], "unii": ["CQ903KQA31"], "rxcui": ["991061"], "spl_set_id": ["600f3b80-0303-4f2d-929b-edb689b5b357"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (31722-052-01)", "package_ndc": "31722-052-01", "marketing_start_date": "20240701"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (31722-052-05)", "package_ndc": "31722-052-05", "marketing_start_date": "20240701"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (31722-052-10)", "package_ndc": "31722-052-10", "marketing_start_date": "20240701"}], "brand_name": "Dicyclomine hydrochloride", "product_id": "31722-052_1e764ead-f2ea-f00c-e063-6294a90ae86b", "dosage_form": "CAPSULE", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "31722-052", "generic_name": "Dicyclomine hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA218018", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}