Gloperba

Product NDC
75854-801
11-digit product format
758540801
Labeler code
75854
Product ID
75854-801_b85547d8-fce6-323d-e053-2995a90a4e7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
SOLUTION
Route
ORAL
Labeler
Avion Pharmaceuticals, LLC
Application
NDA210942
Marketing category
NDA
Marketing start
2019-08-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
1 mg/5mL
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-801-01ML - Milliliter75854-801ec652040-b7f4-4fde-a1f5-bd820d76a23f12019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75854-801-0175854080101150 mL in 1 BOTTLE, PLASTIC (75854-801-01) 150 ml2019-08-010000-00-00NoNoCurrent