FDA.reportPublic FDA data

colchicine

Product NDC
43598-372
11-digit product format
435980372
Labeler code
43598
Product ID
43598-372_1ec57a05-1536-7b6a-a90e-3dd40c9f72d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddys Laboratories, Inc.
Application
ANDA209876
Marketing category
ANDA
Marketing start
2020-06-11
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
43598-372-01colchicine100 in 1 BOTTLETABLET10011
43598-372-10colchicine1000 in 1 BOTTLETABLET100011
43598-372-30colchicine30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-372-01EA - Each43598-3726f728fcc-dfaf-420f-8348-ba02da2add4d12020-07-13
43598-372-30EA - Each43598-37272531e20-f2b9-43ac-8fd1-60a40a27283d12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-372COLCHICINE TABLET [DR.REDDYS LABORATORIES, INC.]9Current NDC, Legacy NDC, 3 package rows20241115_2cd5298e-43c6-a8dc-4467-9a3e1ade9307.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
197541colchicine 0.6 MG Oral TabletPSN2cd5298e-43c6-a8dc-4467-9a3e1ade930711
197541colchicine 0.6 MG Oral TabletSCD2cd5298e-43c6-a8dc-4467-9a3e1ade930711
197541colchicine 600 MCG Oral TabletSY2cd5298e-43c6-a8dc-4467-9a3e1ade930711
197541colchicine 0.6 MG Oral TabletPSN0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 0.6 MG Oral TabletSCD0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 600 MCG Oral TabletSY0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 0.6 MG Oral TabletPSNb414be4e-cd4f-4e7d-bbdd-b406c99c11b63
197541colchicine 0.6 MG Oral TabletPSNd92b7189-78fd-693d-e053-2a95a90a7c733
197541colchicine 0.6 MG Oral TabletSCDb414be4e-cd4f-4e7d-bbdd-b406c99c11b63
197541colchicine 0.6 MG Oral TabletSCDd92b7189-78fd-693d-e053-2a95a90a7c733
197541colchicine 600 MCG Oral TabletSYb414be4e-cd4f-4e7d-bbdd-b406c99c11b63
197541colchicine 600 MCG Oral TabletSYd92b7189-78fd-693d-e053-2a95a90a7c733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-372-0143598037201100 TABLET in 1 BOTTLE (43598-372-01) 100 tablet2020-06-110000-00-00NoNoCurrent
43598-372-10435980372101000 TABLET in 1 BOTTLE (43598-372-10) 1000 tablet2020-09-040000-00-00NoNoCurrent
43598-372-304359803723030 TABLET in 1 BOTTLE (43598-372-30) 30 tablet2020-06-110000-00-00NoNoCurrent