Colchicine

Product NDC
0904-7120
11-digit product format
009047120
Labeler code
0904
Product ID
0904-7120_7542e468-1c98-45ea-9aa2-153bdb40b663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA210425
Marketing category
ANDA
Marketing start
2020-05-13
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
0904-7120-04Colchicine1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7120-04Colchicine30 in 1 CARTONTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7120-04EA - Each0904-71209da7a65f-319e-4fe2-8e1e-dcfad1518e5312021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7120COLCHICINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250207_9e7c8f65-4722-4187-9014-8fa81eb5681e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN9e7c8f65-4722-4187-9014-8fa81eb5681e4
197541colchicine 0.6 MG Oral TabletSCD9e7c8f65-4722-4187-9014-8fa81eb5681e4
197541colchicine 600 MCG Oral TabletSY9e7c8f65-4722-4187-9014-8fa81eb5681e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7120-040090471200430 BLISTER PACK in 1 CARTON (0904-7120-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2020-05-130000-00-00NoNoCurrent