colchicine

Product NDC
70518-4000
11-digit product format
705184000
Labeler code
70518
Product ID
70518-4000_4c61b34c-5d30-3f4e-e063-6294a90a0456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209876
Marketing category
ANDA
Marketing start
2024-01-29
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
70518-4000-0colchicine3 in 1 BOTTLE, PLASTICTABLET33
70518-4000-1colchicine9 in 1 BOTTLE, PLASTICTABLET93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4000COLCHICINE TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20240515_b414be4e-cd4f-4e7d-bbdd-b406c99c11b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNb414be4e-cd4f-4e7d-bbdd-b406c99c11b63
197541colchicine 0.6 MG Oral TabletSCDb414be4e-cd4f-4e7d-bbdd-b406c99c11b63
197541colchicine 600 MCG Oral TabletSYb414be4e-cd4f-4e7d-bbdd-b406c99c11b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4000-0705184000003 in 1 BOTTLE, PLASTICHistorical
70518-4000-1705184000019 TABLET in 1 BOTTLE, PLASTIC (70518-4000-1) 9 tablet2024-05-13NoNoHistorical