Colchicine

Product NDC
70710-1351
11-digit product format
707101351
Labeler code
70710
Product ID
70710-1351_cf874687-3377-4fd3-9616-6c1f74454ad3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211519
Marketing category
ANDA
Marketing start
2019-06-12
Substance
COLCHICEINE
Active strength
.6 mg/1
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
COLCHICEINE.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHJ30158L57

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
70710-1351-1Colchicine1 in 1 CARTONTABLET13
70710-1351-1Colchicine100 in 1 BOTTLETABLET1003
70710-1351-3Colchicine1 in 1 CARTONTABLET13
70710-1351-3Colchicine30 in 1 BOTTLETABLET303
70710-1351-5Colchicine1 in 1 CARTONTABLET13
70710-1351-5Colchicine500 in 1 BOTTLETABLET5003
70710-1351-9Colchicine1 in 1 CARTONTABLET13
70710-1351-9Colchicine90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1351-1EA - Each70710-135189f80e51-bd45-4802-a44c-9f4d6d9ecde612020-09-14
70710-1351-3EA - Each70710-1351b91a9c75-3947-4d8f-880e-9599331cc56112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1351COLCHICINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 8 package rows20221011_c8fd7034-5ca2-4a58-b303-7f78ffdf8d76.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1351-1707101351011 BOTTLE in 1 CARTON (70710-1351-1) / 100 TABLET in 1 BOTTLE1 bottle2019-06-120000-00-00NoNoCurrent
70710-1351-3707101351031 BOTTLE in 1 CARTON (70710-1351-3) / 30 TABLET in 1 BOTTLE1 bottle2019-06-120000-00-00NoNoCurrent
70710-1351-5707101351051 BOTTLE in 1 CARTON (70710-1351-5) / 500 TABLET in 1 BOTTLE1 bottle2019-06-120000-00-00NoNoCurrent
70710-1351-9707101351091 BOTTLE in 1 CARTON (70710-1351-9) / 90 TABLET in 1 BOTTLE1 bottle2019-06-120000-00-00NoNoCurrent