dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler novitium pharma llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 10 mg/5mL

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-261
Product ID 70954-261_b0911994-0b36-439d-8247-5d885a899421
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214721
Listing Expiration 2026-12-31
Marketing Start 2021-04-23

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954261
Hyphenated Format 70954-261

Supplemental Identifiers

RxCUI
991082
UPC
0370954261100
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 ANDA214721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (70954-261-10)
source: ndc

Packages (1)

70954-261-10 473 mL in 1 BOTTLE (70954-261-10)

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": "b0911994-0b36-439d-8247-5d885a899421", "openfda": {"upc": ["0370954261100"], "unii": ["CQ903KQA31"], "rxcui": ["991082"], "spl_set_id": ["b0911994-0b36-439d-8247-5d885a899421"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (70954-261-10)", "package_ndc": "70954-261-10", "marketing_start_date": "20210423"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "70954-261_b0911994-0b36-439d-8247-5d885a899421", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "70954-261", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Novitium Pharma LLC", "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": "20210423", "listing_expiration_date": "20261231"}