FDA.reportPublic FDA data

Colchicine

Product NDC
51407-082
11-digit product format
514070082
Labeler code
51407
Product ID
51407-082_4f73f4fc-b62d-1b2a-e063-6394a90a1654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA210425
Marketing category
ANDA
Marketing start
2020-02-05
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
51407-082-01Colchicine100 in 1 BOTTLETABLET, FILM COATED1007
51407-082-30Colchicine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-082-01EA - Each51407-0820b1bc0f8-bafc-4112-b048-48ffceab72d812020-09-14
51407-082-30EA - Each51407-08237b7e83c-6721-4eac-a15e-ee6306bdc6ab12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-082COLCHICINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 2 package rows20231101_ac12e420-9f29-018e-e053-2a95a90ab612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNac12e420-9f29-018e-e053-2a95a90ab6127
197541colchicine 0.6 MG Oral TabletSCDac12e420-9f29-018e-e053-2a95a90ab6127
197541colchicine 600 MCG Oral TabletSYac12e420-9f29-018e-e053-2a95a90ab6127
197541colchicine 0.6 MG Oral TabletPSNb310c57c-9192-4dc8-b76f-2c1982941caf1
197541colchicine 0.6 MG Oral TabletSCDb310c57c-9192-4dc8-b76f-2c1982941caf1
197541colchicine 600 MCG Oral TabletSYb310c57c-9192-4dc8-b76f-2c1982941caf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-082-0151407008201100 TABLET, FILM COATED in 1 BOTTLE (51407-082-01) 2020-07-240000-00-00NoNoCurrent
51407-082-305140700823030 TABLET, FILM COATED in 1 BOTTLE (51407-082-30) 2020-07-242027-06-30NoNoCurrent