dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

dicyclomine hydrochloride 10 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1559
Product ID 51662-1559_0f8de121-b5e5-3048-e063-6294a90afd7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210257
Listing Expiration 2026-12-31
Marketing Start 2021-07-19

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621559
Hyphenated Format 51662-1559

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 POUCH in 1 CASE (51662-1559-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1559-2) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

51662-1559-3 5 POUCH in 1 CASE (51662-1559-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1559-2) / 2 mL in 1 VIAL, SINGLE-DOSE

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": "0f8de121-b5e5-3048-e063-6294a90afd7c", "openfda": {"unii": ["CQ903KQA31"], "rxcui": ["991065"], "spl_set_id": ["c77ef2f7-a846-5e05-e053-2995a90aaae0"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CASE (51662-1559-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1559-2)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1559-3", "marketing_start_date": "20210719"}], "brand_name": "DICYCLOMINE HYDROCHLORIDE", "product_id": "51662-1559_0f8de121-b5e5-3048-e063-6294a90afd7c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "51662-1559", "generic_name": "DICYCLOMINE HYDROCHLORIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "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": "20210719", "listing_expiration_date": "20261231"}