FDA.reportPublic FDA data

Colchicine

Product NDC
70010-002
11-digit product format
700100002
Labeler code
70010
Product ID
70010-002_018d4e2e-c594-17cf-e063-6294a90a7bb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA210425
Marketing category
ANDA
Marketing start
2020-05-13
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
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
70010-002-01Colchicine100 in 1 BOTTLETABLET, FILM COATED10012
70010-002-03Colchicine30 in 1 BOTTLETABLET, FILM COATED3012
70010-002-10Colchicine1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-002-01EA - Each70010-002342be5d0-d211-46d5-8bd8-c512e7f8623b12020-06-05
70010-002-03EA - Each70010-002631c2c38-18e3-4d9e-a9a0-35689f01acd812020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-002COLCHICINE TABLET, FILM COATED [GRANULES PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 3 package rows20230729_dcf97364-b35f-4bc9-8a92-d3d2e05f47ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSNdcf97364-b35f-4bc9-8a92-d3d2e05f47ac12
197541colchicine 0.6 MG Oral TabletSCDdcf97364-b35f-4bc9-8a92-d3d2e05f47ac12
197541colchicine 600 MCG Oral TabletSYdcf97364-b35f-4bc9-8a92-d3d2e05f47ac12
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 TabletPSNf818ffe0-43df-4cc6-bc86-00b2c79b06fc6
197541colchicine 0.6 MG Oral TabletSCDf818ffe0-43df-4cc6-bc86-00b2c79b06fc6
197541colchicine 600 MCG Oral TabletSYf818ffe0-43df-4cc6-bc86-00b2c79b06fc6
197541colchicine 0.6 MG Oral TabletPSN9e7c8f65-4722-4187-9014-8fa81eb5681e4
197541colchicine 0.6 MG Oral TabletSCD9e7c8f65-4722-4187-9014-8fa81eb5681e4
197541colchicine 600 MCG Oral TabletSY9e7c8f65-4722-4187-9014-8fa81eb5681e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-002-0170010000201100 TABLET, FILM COATED in 1 BOTTLE (70010-002-01) 2020-05-130000-00-00NoNoCurrent
70010-002-037001000020330 TABLET, FILM COATED in 1 BOTTLE (70010-002-03) 2020-05-130000-00-00NoNoCurrent
70010-002-10700100002101000 TABLET, FILM COATED in 1 BOTTLE (70010-002-10) 2023-05-13NoNoHistorical