dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-2261
Product ID 17856-2261_362374f1-a8ef-120d-e063-6394a90a0d6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214721
Listing Expiration 2026-12-31
Marketing Start 2025-03-04

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178562261
Hyphenated Format 17856-2261

Supplemental Identifiers

RxCUI
991082
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 ANDA214721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 72 mL in 1 BOX, UNIT-DOSE (17856-2261-1)
  • 72 mL in 1 BOX, UNIT-DOSE (17856-2261-2)
source: ndc

Packages (2)

17856-2261-1 72 mL in 1 BOX, UNIT-DOSE (17856-2261-1) 17856-2261-2 72 mL in 1 BOX, UNIT-DOSE (17856-2261-2)

Ingredients (1)

dicyclomine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Dicyclomine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "362374f1-a8ef-120d-e063-6394a90a0d6d", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991082"], "spl_set_id": ["2f89e438-6a8a-917e-e063-6294a90a1c23"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 mL in 1 BOX, UNIT-DOSE (17856-2261-1)", "package_ndc": "17856-2261-1", "marketing_start_date": "20250304"}, {"sample": false, "description": "72 mL in 1 BOX, UNIT-DOSE (17856-2261-2)", "package_ndc": "17856-2261-2", "marketing_start_date": "20250304"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "17856-2261_362374f1-a8ef-120d-e063-6394a90a0d6d", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "17856-2261", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA214721", "marketing_category": "ANDA", "marketing_start_date": "20250304", "listing_expiration_date": "20261231"}