FDA.reportPublic FDA data

Colchicine

Product NDC
70518-3851
11-digit product format
705183851
Labeler code
70518
Product ID
70518-3851_43dec4fe-4c65-d38e-e063-6394a90a65b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210425
Marketing category
ANDA
Marketing start
2023-09-02
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
70518-3851-0Colchicine9 in 1 BOTTLE, PLASTICTABLET, FILM COATED96
70518-3851-1Colchicine6 in 1 BOTTLE, PLASTICTABLET, FILM COATED66
70518-3851-2Colchicine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3851COLCHICINE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 3 package rows20240608_f818ffe0-43df-4cc6-bc86-00b2c79b06fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNf818ffe0-43df-4cc6-bc86-00b2c79b06fc6
197541colchicine 0.6 MG Oral TabletSCDf818ffe0-43df-4cc6-bc86-00b2c79b06fc6
197541colchicine 600 MCG Oral TabletSYf818ffe0-43df-4cc6-bc86-00b2c79b06fc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3851-0705183851009 in 1 BOTTLE, PLASTICHistorical
70518-3851-1705183851016 in 1 BOTTLE, PLASTICHistorical
70518-3851-27051838510230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3851-2) 2024-06-06NoNoHistorical