FDA.reportPublic FDA data

colchicine

Product NDC
63629-8362
11-digit product format
636298362
Labeler code
63629
Product ID
63629-8362_3f922884-7115-4509-b5f9-1e93563be69f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211250
Marketing category
ANDA
Marketing start
2019-02-10
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
63629-8362-1colchicine30 in 1 BOTTLETABLET30106
63629-8362-2colchicine20 in 1 BOTTLETABLET20106
63629-8362-3colchicine3 in 1 BOTTLETABLET3106
63629-8362-4colchicine12 in 1 BOTTLETABLET12106
63629-8362-5colchicine6 in 1 BOTTLETABLET6106
63629-8362-6colchicine9 in 1 BOTTLETABLET9106
63629-8362-7colchicine15 in 1 BOTTLETABLET15106
63629-8362-8colchicine10 in 1 BOTTLETABLET10106
63629-8362-9colchicine90 in 1 BOTTLETABLET90106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8362COLCHICINE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 9 package rows20231108_5ae87893-a065-468e-b8da-f1db86afcaef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN5ae87893-a065-468e-b8da-f1db86afcaef106
197541colchicine 0.6 MG Oral TabletSCD5ae87893-a065-468e-b8da-f1db86afcaef106
197541colchicine 600 MCG Oral TabletSY5ae87893-a065-468e-b8da-f1db86afcaef106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8362-16362983620130 TABLET in 1 BOTTLE (63629-8362-1) 30 tablet2020-11-160000-00-00NoNoCurrent
63629-8362-26362983620220 TABLET in 1 BOTTLE (63629-8362-2) 20 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-3636298362033 TABLET in 1 BOTTLE (63629-8362-3) 3 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-46362983620412 TABLET in 1 BOTTLE (63629-8362-4) 12 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-5636298362056 TABLET in 1 BOTTLE (63629-8362-5) 6 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-6636298362069 TABLET in 1 BOTTLE (63629-8362-6) 9 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-76362983620715 TABLET in 1 BOTTLE (63629-8362-7) 15 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-86362983620810 TABLET in 1 BOTTLE (63629-8362-8) 10 tablet2022-09-010000-00-00NoNoCurrent
63629-8362-96362983620990 TABLET in 1 BOTTLE (63629-8362-9) 90 tablet2022-09-01NoNoHistorical