Dicyclomine Hydrochloride

Product NDC
70625-103
11-digit product format
706250103
Labeler code
70625
Product ID
70625-103_b8e7c144-1e3e-928c-e053-2a95a90aa247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Praxgen Pharmaceuticals LLC
Application
ANDA212058
Marketing category
ANDA
Marketing start
2019-11-04
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/2mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70625-103-05706250103055 VIAL in 1 BOX (70625-103-05) > 2 mL in 1 VIAL (70625-103-01) 5 vial2019-11-040000-00-00NoNoCurrent