FDA.reportPublic FDA data

Colchicine

Product NDC
71335-2703
11-digit product format
713352703
Labeler code
71335
Product ID
71335-2703_1327bc34-48ec-47da-879a-a3e7ebd369a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215463
Marketing category
ANDA
Marketing start
2024-04-29
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
Rxcui1550940

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
71335-2703-1Colchicine30 in 1 BOTTLECAPSULE301
71335-2703-2Colchicine10 in 1 BOTTLECAPSULE101
71335-2703-3Colchicine8 in 1 BOTTLECAPSULE81
71335-2703-4Colchicine90 in 1 BOTTLECAPSULE901
71335-2703-5Colchicine60 in 1 BOTTLECAPSULE601
71335-2703-6Colchicine3 in 1 BOTTLECAPSULE31
71335-2703-7Colchicine20 in 1 BOTTLECAPSULE201
71335-2703-8Colchicine6 in 1 BOTTLECAPSULE61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSNd83c6ae4-a41c-4b14-94b3-2d93c9aa28d11
1550940colchicine 0.6 MG Oral CapsuleSCDd83c6ae4-a41c-4b14-94b3-2d93c9aa28d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2703-17133527030130 CAPSULE in 1 BOTTLE (71335-2703-1) 30 capsule2025-09-26NoNoHistorical
71335-2703-27133527030210 CAPSULE in 1 BOTTLE (71335-2703-2) 10 capsule2025-09-26NoNoHistorical
71335-2703-3713352703038 CAPSULE in 1 BOTTLE (71335-2703-3) 8 capsule2025-09-26NoNoHistorical
71335-2703-47133527030490 CAPSULE in 1 BOTTLE (71335-2703-4) 90 capsule2025-09-26NoNoHistorical
71335-2703-57133527030560 CAPSULE in 1 BOTTLE (71335-2703-5) 60 capsule2025-09-26NoNoHistorical
71335-2703-6713352703063 CAPSULE in 1 BOTTLE (71335-2703-6) 3 capsule2025-09-26NoNoHistorical
71335-2703-77133527030720 CAPSULE in 1 BOTTLE (71335-2703-7) 20 capsule2025-09-26NoNoHistorical
71335-2703-8713352703086 CAPSULE in 1 BOTTLE (71335-2703-8) 6 capsule2025-09-26NoNoHistorical