dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

dicyclomine hydrochloride 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-842
Product ID 63323-842_19096abe-de13-44f4-9028-f918519e34f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210257
Listing Expiration 2026-12-31
Marketing Start 2019-09-12

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323842
Hyphenated Format 63323-842

Supplemental Identifiers

RxCUI
991065
UPC
0363323842215
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 ANDA210257 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21)
source: ndc

Packages (1)

63323-842-02 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21)

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": "19096abe-de13-44f4-9028-f918519e34f5", "openfda": {"upc": ["0363323842215"], "unii": ["CQ903KQA31"], "rxcui": ["991065"], "spl_set_id": ["350ce812-b9a7-401a-9793-55d2e14bb760"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21)", "package_ndc": "63323-842-02", "marketing_start_date": "20190912"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "63323-842_19096abe-de13-44f4-9028-f918519e34f5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "63323-842", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA210257", "marketing_category": "ANDA", "marketing_start_date": "20190912", "listing_expiration_date": "20261231"}