Dicyclomine HCl

Product NDC
14789-010
11-digit product format
147890010
Labeler code
14789
Product ID
14789-010_67f7309d-c2ed-40ec-8cdb-4ef1ab3b7047
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Nexus Pharmaceuticals Inc.
Application
ANDA206468
Marketing category
ANDA
Marketing start
2019-02-18
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-010-02ML - Milliliter14789-0105da956cc-75f1-4e1d-96c2-569663eabfbd12019-03-12
14789-010-07ML - Milliliter14789-0109d038c07-6357-414a-8084-7c3ffec9b41a12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-010DICYCLOMINE HCL (DICYCLOMINE HYDROCHLORIDE) INJECTION [NEXUS PHARMACEUTICALS LLC]14Legacy NDC20250326_be216fa1-e509-4ae5-a62a-550881d090ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14789-010-02147890010025 VIAL, SINGLE-DOSE in 1 CARTON (14789-010-02) > 2 mL in 1 VIAL, SINGLE-DOSE2019-02-180000-00-00NoNoCurrent