FDA.reportPublic FDA data

Colcrys

Product NDC
13310-119
11-digit product format
133100119
Labeler code
13310
Product ID
13310-119_d6eb54b7-2050-4449-85b8-1592cec62176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AR Scientific Inc.
Application
NDA022352
Marketing category
NDA
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
1 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13310-119-012019-11-13C16284748780-197449f38-d17e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-032019-11-13C16284748780-197449f38-d17e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-052019-11-13C16284748780-197449f38-d17e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-062019-11-13C16284748780-197449f38-d17e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-072019-11-13C16284748780-197449f38-d17e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-102019-11-13C16284748780-197449f38-d17e-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13310-119-01Colcrys100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
13310-119-03Colcrys250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25014
13310-119-05Colcrys500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50014
13310-119-06Colcrys60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014
13310-119-07Colcrys30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
13310-119-10Colcrys1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13310-119-01EA - Each13310-119958894f5-b1df-4d90-b456-89d8ea5c83f112012-07-24
13310-119-07EA - Each13310-119665b9f02-4226-4ee4-b2fd-5352a76a245a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ColchicineACTIVE INGREDIENTSML2Y3J35TCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
ColchicineACTIVE MOIETYSML2Y3J35TCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
magnesium stearateINACTIVE INGREDIENT70097M6I30COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
polydextroseINACTIVE INGREDIENTVH2XOU12IECOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
starch, cornINACTIVE INGREDIENTO8232NY3SJCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCOLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
triacetinINACTIVE INGREDIENTXHX3C3X673COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14
ColchicineACTIVE INGREDIENTSML2Y3J35TCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ColchicineACTIVE MOIETYSML2Y3J35TCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
polydextroseINACTIVE INGREDIENTVH2XOU12IECOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCOLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13310-119COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]14Legacy NDC, 6 package rows20120604_5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
858071Colcrys 0.6 MG Oral TabletPSN5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
858071colchicine 0.6 MG Oral Tablet [Colcrys]SBD5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
197541colchicine 0.6 MG Oral TabletSCD5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
197541colchicine 600 MCG Oral TabletSY5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
858071Colcrys (colchicine 0.6 MG) Oral TabletSY5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
858071Colcrys 0.6 MG Oral TabletSY5ecaa34e-1bed-49a5-b97c-a8f8c0d885a714
197541colchicine 0.6 MG Oral TabletPSN4e936802-5b5d-4772-8b1d-4f30867ffa592
858071Colcrys 0.6 MG Oral TabletPSN4e936802-5b5d-4772-8b1d-4f30867ffa592
858071colchicine 0.6 MG Oral Tablet [Colcrys]SBD4e936802-5b5d-4772-8b1d-4f30867ffa592
197541colchicine 0.6 MG Oral TabletSCD4e936802-5b5d-4772-8b1d-4f30867ffa592
197541colchicine 600 MCG Oral TabletSY4e936802-5b5d-4772-8b1d-4f30867ffa592
858071Colcrys (colchicine 0.6 MG) Oral TabletSY4e936802-5b5d-4772-8b1d-4f30867ffa592
858071Colcrys 0.6 MG Oral TabletSY4e936802-5b5d-4772-8b1d-4f30867ffa592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13310-119-0113310011901100 in 1 BOTTLE, PLASTICHistorical
13310-119-0313310011903250 in 1 BOTTLE, PLASTICHistorical
13310-119-0513310011905500 in 1 BOTTLE, PLASTICHistorical
13310-119-061331001190660 in 1 BOTTLE, PLASTICHistorical
13310-119-071331001190730 in 1 BOTTLE, PLASTICHistorical
13310-119-10133100119101000 in 1 BOTTLE, PLASTICHistorical