Colchicine

Product NDC
0254-2008
11-digit product format
002542008
Labeler code
0254
Product ID
0254-2008_bd7a3243-fb43-40fa-8a57-81c063d79a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
NDA022352
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-07-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
1 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Alkaloid [EPC],Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51989a2b-944a-b31f-835e-469c133570adProduct name220250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2Product name220250214
14efe2b0-2695-4943-8b2f-24f519c99fedProduct name120231023
bf4e8ffd-8f13-3050-5248-581676b7ea42Product name620221214
987af351-b977-4822-ac44-c76d29e24e78Product name120190611

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0254-2008-01Colchicine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
0254-2008-11Colchicine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0254-2008-01EA - Each0254-200877906ac2-97d0-4066-94d1-f168d056868112018-07-03
0254-2008-11EA - Each0254-2008cd281ad2-bec4-426d-8980-d3cc7687ad4212018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0254-2008COLCHICINE TABLET, FILM COATED [PAR PHARMACEUTICAL, INC.]3Legacy NDC, 2 package rows20211202_fc439ae8-a79e-4942-8d02-22422b19b015.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNa15538ee-d1eb-4118-97c3-53748cea012a104
197541colchicine 0.6 MG Oral TabletSCDa15538ee-d1eb-4118-97c3-53748cea012a104
197541colchicine 600 MCG Oral TabletSYa15538ee-d1eb-4118-97c3-53748cea012a104
197541colchicine 0.6 MG Oral TabletPSN5e5d9488-d9d0-4b37-b535-941d66c3430d103
197541colchicine 0.6 MG Oral TabletPSNdf1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96103
197541colchicine 0.6 MG Oral TabletSCD5e5d9488-d9d0-4b37-b535-941d66c3430d103
197541colchicine 0.6 MG Oral TabletSCDdf1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96103
197541colchicine 600 MCG Oral TabletSY5e5d9488-d9d0-4b37-b535-941d66c3430d103
197541colchicine 600 MCG Oral TabletSYdf1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96103
197541colchicine 0.6 MG Oral TabletPSN96ca32da-68cc-d757-e053-2995a90a76d87
197541colchicine 0.6 MG Oral TabletSCD96ca32da-68cc-d757-e053-2995a90a76d87
197541colchicine 600 MCG Oral TabletSY96ca32da-68cc-d757-e053-2995a90a76d87
197541colchicine 0.6 MG Oral TabletPSNfc439ae8-a79e-4942-8d02-22422b19b0153
197541colchicine 0.6 MG Oral TabletSCDfc439ae8-a79e-4942-8d02-22422b19b0153
197541colchicine 600 MCG Oral TabletSYfc439ae8-a79e-4942-8d02-22422b19b0153
197541colchicine 0.6 MG Oral TabletPSNc7d013b7-0a67-0953-e053-2a95a90ac47c2
197541colchicine 0.6 MG Oral TabletSCDc7d013b7-0a67-0953-e053-2a95a90ac47c2
197541colchicine 600 MCG Oral TabletSYc7d013b7-0a67-0953-e053-2a95a90ac47c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0254-2008-0100254200801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-01) 2018-07-010000-00-00NoNoCurrent
0254-2008-110025420081130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-11) 2018-07-010000-00-00NoNoCurrent