Colchicine

Product NDC
72789-572
11-digit product format
727890572
Labeler code
72789
Product ID
72789-572_5245af45-77cc-c95f-e063-6294a90a24f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208993
Marketing category
ANDA
Marketing start
2021-08-13
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
72789-572-30Colchicine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN68d4bf2b-8e2c-4621-aa08-463f43e253c32
197541colchicine 0.6 MG Oral TabletSCD68d4bf2b-8e2c-4621-aa08-463f43e253c32
197541colchicine 600 MCG Oral TabletSY68d4bf2b-8e2c-4621-aa08-463f43e253c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-572-307278905723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-572-30) 2026-05-20NoNoHistorical