FDA.reportPublic FDA data

Colchicine

Product NDC
70010-001
11-digit product format
700100001
Labeler code
70010
Product ID
70010-001_3836b9fe-5628-fe23-e063-6294a90aa475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceutical Inc.
Application
ANDA210757
Marketing category
ANDA
Marketing start
2024-04-29
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
Rxcui1550940

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
70010-001-01Colchicine100 in 1 BOTTLECAPSULE1004
70010-001-03Colchicine30 in 1 BOTTLECAPSULE304
70010-001-10Colchicine1000 in 1 BOTTLECAPSULE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-001COLCHICINE CAPSULE [GRANULES PHARMACEUTICAL INC.]3Current NDC, 3 package rows20240829_16d49c45-5b0a-a7fa-e063-6294a90a7320.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSN16d49c45-5b0a-a7fa-e063-6294a90a73204
1550940colchicine 0.6 MG Oral CapsuleSCD16d49c45-5b0a-a7fa-e063-6294a90a73204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-001-0170010000101100 CAPSULE in 1 BOTTLE (70010-001-01) 100 capsule2024-04-29NoNoCurrent
70010-001-037001000010330 CAPSULE in 1 BOTTLE (70010-001-03) 30 capsule2024-08-22NoNoCurrent
70010-001-10700100001101000 CAPSULE in 1 BOTTLE (70010-001-10) 1000 capsule2024-04-29NoNoCurrent