Colchicine

Product NDC
42292-054
11-digit product format
422920054
Labeler code
42292
Product ID
42292-054_e2b0862b-5cc1-d072-e053-2995a90a6ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA209470
Marketing category
ANDA
Marketing start
2020-04-30
Marketing end
2030-01-31
Substance
COLCHICINE
Active strength
1 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-054-01EA - Each42292-054bb349230-f28e-46a9-a53b-e9f159609d6312020-04-20
42292-054-03EA - Each42292-0540df60885-1130-4496-8193-f9df2ab9e74512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42292-054COLCHICINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]11Legacy NDC20240618_5d8d511a-0851-4d0a-a01a-f43398b63a06.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42292-054-034229200540330 BLISTER PACK in 1 CARTON (42292-054-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-054-01) 30 blister pack2020-04-280000-00-00NoNoCurrent