FDA.reportPublic FDA data

colchicine

Product NDC
71335-1738
11-digit product format
713351738
Labeler code
71335
Product ID
71335-1738_ba40dbb7-2983-4797-b285-92fdb5b563d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209876
Marketing category
ANDA
Marketing start
2020-06-11
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
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
71335-1738-1colchicine30 in 1 BOTTLETABLET30103
71335-1738-2colchicine20 in 1 BOTTLETABLET20103
71335-1738-3colchicine3 in 1 BOTTLETABLET3103
71335-1738-4colchicine12 in 1 BOTTLETABLET12103
71335-1738-5colchicine6 in 1 BOTTLETABLET6103
71335-1738-6colchicine9 in 1 BOTTLETABLET9103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1738COLCHICINE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20231108_14d4be16-d355-4baf-b4cd-4d97d4b2dca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN14d4be16-d355-4baf-b4cd-4d97d4b2dca0103
197541colchicine 0.6 MG Oral TabletSCD14d4be16-d355-4baf-b4cd-4d97d4b2dca0103
197541colchicine 600 MCG Oral TabletSY14d4be16-d355-4baf-b4cd-4d97d4b2dca0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1738-17133517380130 TABLET in 1 BOTTLE (71335-1738-1) 30 tablet2020-11-230000-00-00NoNoCurrent
71335-1738-27133517380220 TABLET in 1 BOTTLE (71335-1738-2) 20 tablet2022-01-280000-00-00NoNoCurrent
71335-1738-3713351738033 TABLET in 1 BOTTLE (71335-1738-3) 3 tablet2020-12-090000-00-00NoNoCurrent
71335-1738-47133517380412 TABLET in 1 BOTTLE (71335-1738-4) 12 tablet2022-01-280000-00-00NoNoCurrent
71335-1738-5713351738056 TABLET in 1 BOTTLE (71335-1738-5) 6 tablet2022-01-280000-00-00NoNoCurrent
71335-1738-6713351738069 TABLET in 1 BOTTLE (71335-1738-6) 9 tablet2022-01-280000-00-00NoNoCurrent