dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

dicyclomine hydrochloride 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6173
Product ID 0641-6173_856c880c-b430-43a3-a225-1fb783b6c0ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040465
Listing Expiration 2026-12-31
Marketing Start 2015-12-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416173
Hyphenated Format 0641-6173

Supplemental Identifiers

RxCUI
991065
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 ANDA040465 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01)
source: ndc

Packages (1)

0641-6173-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01)

Ingredients (1)

dicyclomine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Dicyclomine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "856c880c-b430-43a3-a225-1fb783b6c0ea", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991065"], "spl_set_id": ["26a94263-46c0-4938-849c-ffb396e48dd3"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01)", "package_ndc": "0641-6173-10", "marketing_start_date": "20151230"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "0641-6173_856c880c-b430-43a3-a225-1fb783b6c0ea", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0641-6173", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA040465", "marketing_category": "ANDA", "marketing_start_date": "20151230", "listing_expiration_date": "20261231"}