FDA.reportPublic FDA data

Colchicine

Product NDC
71335-2791
11-digit product format
713352791
Labeler code
71335
Product ID
71335-2791_e4d9651d-0570-418b-8a5e-c3d2b99bb3c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208993
Marketing category
ANDA
Marketing start
2021-08-13
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
71335-2791-1Colchicine30 in 1 BOTTLETABLET, FILM COATED30101
71335-2791-2Colchicine20 in 1 BOTTLETABLET, FILM COATED20101
71335-2791-3Colchicine3 in 1 BOTTLETABLET, FILM COATED3101
71335-2791-4Colchicine12 in 1 BOTTLETABLET, FILM COATED12101
71335-2791-5Colchicine6 in 1 BOTTLETABLET, FILM COATED6101
71335-2791-6Colchicine9 in 1 BOTTLETABLET, FILM COATED9101
71335-2791-7Colchicine15 in 1 BOTTLETABLET, FILM COATED15101
71335-2791-8Colchicine10 in 1 BOTTLETABLET, FILM COATED10101
71335-2791-9Colchicine90 in 1 BOTTLETABLET, FILM COATED90101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN5cefec2e-1982-4417-8d99-5711231b3933101
197541colchicine 0.6 MG Oral TabletSCD5cefec2e-1982-4417-8d99-5711231b3933101
197541colchicine 600 MCG Oral TabletSY5cefec2e-1982-4417-8d99-5711231b3933101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2791-17133527910130 TABLET, FILM COATED in 1 BOTTLE (71335-2791-1) 2026-03-12NoNoHistorical
71335-2791-27133527910220 TABLET, FILM COATED in 1 BOTTLE (71335-2791-2) 2026-03-12NoNoHistorical
71335-2791-3713352791033 TABLET, FILM COATED in 1 BOTTLE (71335-2791-3) 2026-03-12NoNoHistorical
71335-2791-47133527910412 TABLET, FILM COATED in 1 BOTTLE (71335-2791-4) 2026-03-12NoNoHistorical
71335-2791-5713352791056 TABLET, FILM COATED in 1 BOTTLE (71335-2791-5) 2026-03-12NoNoHistorical
71335-2791-6713352791069 TABLET, FILM COATED in 1 BOTTLE (71335-2791-6) 2026-03-12NoNoHistorical
71335-2791-77133527910715 TABLET, FILM COATED in 1 BOTTLE (71335-2791-7) 2026-03-12NoNoHistorical
71335-2791-87133527910810 TABLET, FILM COATED in 1 BOTTLE (71335-2791-8) 2026-03-12NoNoHistorical
71335-2791-97133527910990 TABLET, FILM COATED in 1 BOTTLE (71335-2791-9) 2026-03-12NoNoHistorical