FDA.reportPublic FDA data

Colchicine

Product NDC
23155-855
11-digit product format
231550855
Labeler code
23155
Product ID
23155-855_9031a018-6f13-4302-ab8b-084b672f5f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA209173
Marketing category
ANDA
Marketing start
2023-03-26
Marketing end
2026-07-31
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colchicine

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
23155-855-01Colchicine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
23155-855-03Colchicine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-855-01EA - Each23155-855171846f5-adab-47f5-8798-5b65f7f8e4cc12023-07-06
23155-855-03EA - Each23155-8559c054304-a018-46b2-8741-758e5a8e3ac612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-855COLCHICINE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230326_28efb8cf-3ef4-4cd6-b6f6-131f3ca01112.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN28efb8cf-3ef4-4cd6-b6f6-131f3ca011123
197541colchicine 0.6 MG Oral TabletSCD28efb8cf-3ef4-4cd6-b6f6-131f3ca011123
197541colchicine 600 MCG Oral TabletSY28efb8cf-3ef4-4cd6-b6f6-131f3ca011123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-855-0123155085501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-855-01) 2023-03-262026-07-31NoNoHistorical
23155-855-032315508550330 in 1 BOTTLE, PLASTICHistorical