FDA.reportPublic FDA data

Colchicine

Product NDC
65162-710
11-digit product format
651620710
Labeler code
65162
Product ID
65162-710_74974eef-499f-456f-8683-da23bb0c1137
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204711
Marketing category
ANDA
Marketing start
2016-09-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-710-03Colchicine30 in 1 BOTTLETABLET3018
65162-710-09Colchicine90 in 1 BOTTLETABLET9018
65162-710-11Colchicine1000 in 1 BOTTLETABLET100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-710-03EA - Each65162-7100b80f139-ae7f-49c3-86a6-b161195878e412020-06-05
65162-710-09EA - Each65162-710608514f9-bbcc-4af1-bc38-d5142e93070012020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-710COLCHICINE TABLET [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 3 package rows20250328_7daef7e2-888d-4116-81a9-2c02b9ef97ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN7daef7e2-888d-4116-81a9-2c02b9ef97ef18
197541colchicine 0.6 MG Oral TabletSCD7daef7e2-888d-4116-81a9-2c02b9ef97ef18
197541colchicine 600 MCG Oral TabletSY7daef7e2-888d-4116-81a9-2c02b9ef97ef18
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
65162-710-036516207100330 TABLET in 1 BOTTLE (65162-710-03) 30 tablet2016-09-300000-00-00NoNoCurrent
65162-710-096516207100990 TABLET in 1 BOTTLE (65162-710-09) 90 tablet2016-09-300000-00-00NoNoCurrent
65162-710-11651620710111000 TABLET in 1 BOTTLE (65162-710-11) 1000 tablet2016-09-300000-00-00NoNoCurrent