FDA.reportPublic FDA data

colchicine

Product NDC
68071-2567
11-digit product format
680712567
Labeler code
68071
Product ID
68071-2567_2b615ac9-9f1b-59ee-e063-6294a90a30d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211250
Marketing category
ANDA
Marketing start
2019-02-10
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2567-92025-01-10C16284748780-1f386c64a-2fa3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use COLCHICINE TABLETS safely and effectively. See full prescribing information for COLCHICINE TABLETS. COLCHICINE tablets, for oral use Initial U.S. Approval: 1961
68071-2567-92023-01-30C16284748780-1f386c64a-2fa3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use COLCHICINE TABLETS safely and effectively. See full prescribing information for COLCHICINE TABLETS. COLCHICINE tablets, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2567-9colchicine90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2567COLCHICINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20250112_d010a735-1a20-23fe-e053-2995a90abe0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNd010a735-1a20-23fe-e053-2995a90abe0f2
197541colchicine 0.6 MG Oral TabletSCDd010a735-1a20-23fe-e053-2995a90abe0f2
197541colchicine 600 MCG Oral TabletSYd010a735-1a20-23fe-e053-2995a90abe0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2567-96807125670990 TABLET in 1 BOTTLE (68071-2567-9) 90 tablet2021-11-050000-00-00NoNoCurrent