Colchicine

Product NDC
33342-341
11-digit product format
333420341
Labeler code
33342
Product ID
33342-341_9111bbad-b020-44fb-b276-d7853e5acd2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA210633
Marketing category
ANDA
Marketing start
2017-04-24
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
33342-341-07Colchicine30 in 1 BOTTLETABLET301
33342-341-11Colchicine100 in 1 BOTTLETABLET1001
33342-341-15Colchicine500 in 1 BOTTLETABLET5001
33342-341-42Colchicine10 in 1 BLISTER PACKTABLET101
33342-341-42Colchicine11 in 1 CARTONTABLET111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN9111bbad-b020-44fb-b276-d7853e5acd2c1
197541colchicine 0.6 MG Oral TabletSCD9111bbad-b020-44fb-b276-d7853e5acd2c1
197541colchicine 600 MCG Oral TabletSY9111bbad-b020-44fb-b276-d7853e5acd2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-341-073334203410730 TABLET in 1 BOTTLE (33342-341-07) 30 tablet2018-08-23NoNoCurrent
33342-341-1133342034111100 TABLET in 1 BOTTLE (33342-341-11) 100 tablet2018-08-23NoNoCurrent
33342-341-1533342034115500 TABLET in 1 BOTTLE (33342-341-15) 500 tablet2018-08-23NoNoCurrent
33342-341-423334203414211 BLISTER PACK in 1 CARTON (33342-341-42) / 10 TABLET in 1 BLISTER PACK11 blister pack2018-08-23NoNoCurrent