FDA.reportPublic FDA data

Colchicine

Product NDC
71335-1802
11-digit product format
713351802
Labeler code
71335
Product ID
71335-1802_8581b1aa-ce40-4d11-9191-ad7a23ddeb94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA022352
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-07-01
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
71335-1802-1Colchicine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30104
71335-1802-2Colchicine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED20104
71335-1802-3Colchicine3 in 1 BOTTLE, PLASTICTABLET, FILM COATED3104
71335-1802-4Colchicine12 in 1 BOTTLE, PLASTICTABLET, FILM COATED12104
71335-1802-5Colchicine6 in 1 BOTTLE, PLASTICTABLET, FILM COATED6104
71335-1802-6Colchicine9 in 1 BOTTLE, PLASTICTABLET, FILM COATED9104
71335-1802-7Colchicine15 in 1 BOTTLE, PLASTICTABLET, FILM COATED15104
71335-1802-8Colchicine10 in 1 BOTTLE, PLASTICTABLET, FILM COATED10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1802COLCHICINE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 8 package rows20240524_a15538ee-d1eb-4118-97c3-53748cea012a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNa15538ee-d1eb-4118-97c3-53748cea012a104
197541colchicine 0.6 MG Oral TabletSCDa15538ee-d1eb-4118-97c3-53748cea012a104
197541colchicine 600 MCG Oral TabletSYa15538ee-d1eb-4118-97c3-53748cea012a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1802-17133518020130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-1) 2021-06-110000-00-00NoNoCurrent
71335-1802-27133518020220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-2) 2021-06-110000-00-00NoNoCurrent
71335-1802-3713351802033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-3) 2021-06-110000-00-00NoNoCurrent
71335-1802-47133518020412 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-4) 2021-06-110000-00-00NoNoCurrent
71335-1802-5713351802056 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-5) 2022-05-040000-00-00NoNoCurrent
71335-1802-6713351802069 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-6) 2021-12-030000-00-00NoNoCurrent
71335-1802-77133518020715 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-7) 2022-03-280000-00-00NoNoCurrent
71335-1802-87133518020810 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1802-8) 2022-03-100000-00-00NoNoCurrent