FDA.reportPublic FDA data

Colchicine

Product NDC
49884-171
11-digit product format
498840171
Labeler code
49884
Product ID
49884-171_7503eeb8-f535-4686-b18b-b2d2f61d82a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA203976
Marketing category
ANDA
Marketing start
2022-09-27
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
49884-171-01Colchicine100 in 1 BOTTLETABLET, FILM COATED10010
49884-171-11Colchicine30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-171-01EA - Each49884-171891da462-94ba-416a-8755-a107f52b6ad812023-01-09
49884-171-11EA - Each49884-1717e86a0a8-e670-42ff-bd47-c67c0f032a8f12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-171COLCHICINE TABLET, FILM COATED [ENDO USA, INC.]8Current NDC, Legacy NDC, 2 package rows20240926_72984aa2-6df9-4460-9926-399ffed30e36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN72984aa2-6df9-4460-9926-399ffed30e3610
197541colchicine 0.6 MG Oral TabletSCD72984aa2-6df9-4460-9926-399ffed30e3610
197541colchicine 600 MCG Oral TabletSY72984aa2-6df9-4460-9926-399ffed30e3610
197541colchicine 0.6 MG Oral TabletPSN4b79a786-3f9e-4dad-aa66-bae5f299b9667
197541colchicine 0.6 MG Oral TabletSCD4b79a786-3f9e-4dad-aa66-bae5f299b9667
197541colchicine 600 MCG Oral TabletSY4b79a786-3f9e-4dad-aa66-bae5f299b9667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-171-0149884017101100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01) 2022-09-270000-00-00NoNoCurrent
49884-171-114988401711130 TABLET, FILM COATED in 1 BOTTLE (49884-171-11) 2022-09-270000-00-00NoNoCurrent