Colchicine

Product NDC
0591-2562
11-digit product format
005912562
Labeler code
0591
Product ID
0591-2562_1a2cbb1f-af4c-4f84-83aa-3e59d5859758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204461
Marketing category
ANDA
Marketing start
2020-12-02
Marketing end
0000-00-00
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
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
0591-2562-01EA - Each0591-25624418f6ab-4606-4725-a0bd-bd5e54ef4aea12021-01-08
0591-2562-30EA - Each0591-2562ad7bc5bb-c3b3-4fa3-b297-83e7481cc64d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2562COLCHICINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]6Legacy NDC20250226_9e5b59cb-1749-4999-83d0-b82097515e4b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2562-0100591256201100 TABLET, FILM COATED in 1 BOTTLE (0591-2562-01) 2020-12-020000-00-00NoNoCurrent
0591-2562-300059125623030 TABLET, FILM COATED in 1 BOTTLE (0591-2562-30) 2020-12-020000-00-00NoNoCurrent