Colchicine

Product NDC
67046-0889
11-digit product format
670460889
Labeler code
67046
Product ID
67046-0889_313e65c4-3402-27b4-e063-6294a90a8134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
NDA204820
Marketing category
NDA
Marketing start
2025-01-27
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colchicine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSML2Y3J35T
Rxcui1550940

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
67046-0889-3Colchicine30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-0889COLCHICINE CAPSULE [COUPLER LLC]2Current NDC, 1 package rows20250327_2cb88c93-54b8-a548-e063-6294a90a94e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSN2cb88c93-54b8-a548-e063-6294a90a94e62
1550940colchicine 0.6 MG Oral CapsuleSCD2cb88c93-54b8-a548-e063-6294a90a94e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0889-36704608890330 CAPSULE in 1 BLISTER PACK (67046-0889-3) 30 capsule2025-01-27NoNoCurrent