FDA.reportPublic FDA data

colchicine

Product NDC
71205-687
11-digit product format
712050687
Labeler code
71205
Product ID
71205-687_62a7d89d-9856-446f-aaa2-962825fef0a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209876
Marketing category
ANDA
Marketing start
2020-06-11
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
71205-687-05colchicine5 in 1 BOTTLETABLET54
71205-687-10colchicine10 in 1 BOTTLETABLET104
71205-687-21colchicine21 in 1 BOTTLETABLET214
71205-687-30colchicine30 in 1 BOTTLETABLET304
71205-687-60colchicine60 in 1 BOTTLETABLET604
71205-687-90colchicine90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-687COLCHICINE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20250501_0f69b9c6-8c00-45e2-b950-34dc5ae62352.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 0.6 MG Oral TabletSCD0f69b9c6-8c00-45e2-b950-34dc5ae623524
197541colchicine 600 MCG Oral TabletSY0f69b9c6-8c00-45e2-b950-34dc5ae623524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-687-05712050687055 TABLET in 1 BOTTLE (71205-687-05) 5 tablet2025-07-17NoNoCurrent
71205-687-107120506871010 TABLET in 1 BOTTLE (71205-687-10) 10 tablet2022-10-270000-00-00NoNoCurrent
71205-687-217120506872121 TABLET in 1 BOTTLE (71205-687-21) 21 tablet2025-04-25NoNoCurrent
71205-687-307120506873030 TABLET in 1 BOTTLE (71205-687-30) 30 tablet2022-08-220000-00-00NoNoCurrent
71205-687-607120506876060 TABLET in 1 BOTTLE (71205-687-60) 60 tablet2022-08-220000-00-00NoNoCurrent
71205-687-907120506879090 TABLET in 1 BOTTLE (71205-687-90) 90 tablet2022-08-220000-00-00NoNoCurrent