Colchicine

Product NDC
50268-187
11-digit product format
502680187
Labeler code
50268
Product ID
50268-187_47e2f7f3-445a-dc42-e063-6294a90a4ba8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA204711
Marketing category
ANDA
Marketing start
2021-09-15
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colchicine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSML2Y3J35T
Rxcui197541

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-187-11Colchicine1 in 1 BLISTER PACKTABLET14
50268-187-15Colchicine50 in 1 BOXTABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-187-11EA - Each50268-1873f610e9a-103d-4f7d-8720-34428a0c5b3212021-10-08
50268-187-15EA - Each50268-1876ee65293-a763-4c1a-859b-d849e6b62af112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-187COLCHICINE TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_cc0e205a-697e-d47e-e053-2995a90a154e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNcc0e205a-697e-d47e-e053-2995a90a154e4
197541colchicine 0.6 MG Oral TabletSCDcc0e205a-697e-d47e-e053-2995a90a154e4
197541colchicine 600 MCG Oral TabletSYcc0e205a-697e-d47e-e053-2995a90a154e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-187-11502680187111 in 1 BLISTER PACKHistorical
50268-187-155026801871550 BLISTER PACK in 1 BOX (50268-187-15) / 1 TABLET in 1 BLISTER PACK (50268-187-11) 50 blister pack2021-09-150000-00-00NoNoCurrent