Colchicine

Product NDC
59651-455
11-digit product format
596510455
Labeler code
59651
Product ID
59651-455_eedd0f18-16dc-4404-bc85-507ec93049e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA215444
Marketing category
ANDA
Marketing start
2022-03-22
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
59651-455-01Colchicine100 in 1 BOTTLETABLET1002
59651-455-30Colchicine30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-455-01EA - Each59651-455e7ea27a1-aa34-4bf6-852a-472632a0e4bf12022-11-07
59651-455-30EA - Each59651-455241899a5-fb55-4f21-b575-2508311b470012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-455COLCHICINE TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 2 package rows20220323_dd93a40f-92ab-47ac-9083-b8a7a0b18ad6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNdd93a40f-92ab-47ac-9083-b8a7a0b18ad62
197541colchicine 0.6 MG Oral TabletSCDdd93a40f-92ab-47ac-9083-b8a7a0b18ad62
197541colchicine 600 MCG Oral TabletSYdd93a40f-92ab-47ac-9083-b8a7a0b18ad62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-455-0159651045501100 TABLET in 1 BOTTLE (59651-455-01) 100 tablet2022-03-220000-00-00NoNoCurrent
59651-455-305965104553030 TABLET in 1 BOTTLE (59651-455-30) 30 tablet2022-03-220000-00-00NoNoCurrent