FDA.reportPublic FDA data

Colchicine

Product NDC
50090-3465
11-digit product format
500903465
Labeler code
50090
Product ID
50090-3465_0a10fc69-7083-42e4-9b2f-edbd0099017e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA204820
Marketing category
NDA
Marketing start
2014-10-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3465-02022-10-05C16284748780-19d75b9cf-cf26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COLCHICINE CAPSULES safely and effectively. See full prescribing information for COLCHICINE CAPSULES. COLCHICINE capsules, for oral use Initial U.S. Approval: 1961
50090-3465-02020-01-31C16284748780-19d75b9cf-cf26-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use COLCHICINE CAPSULES safely and effectively. See full prescribing information for COLCHICINE CAPSULES. COLCHICINE capsules, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3465-0Colchicine4 in 1 BOTTLECAPSULE414
50090-3465-1Colchicine90 in 1 BOTTLECAPSULE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3465-0EA - Each50090-3465ed26be27-8fb2-4bef-8fe4-cb37be3a779712019-05-02
50090-3465-1EA - Each50090-34651ab3b00a-ef22-48ad-a2f8-808859121f8612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3465COLCHICINE CAPSULE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20240606_25307250-c16b-4467-9ad0-e6c752c576bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSN25307250-c16b-4467-9ad0-e6c752c576bd14
1550940colchicine 0.6 MG Oral CapsuleSCD25307250-c16b-4467-9ad0-e6c752c576bd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3465-0500903465004 CAPSULE in 1 BOTTLE (50090-3465-0) 4 capsule2018-05-300000-00-00NoNoCurrent
50090-3465-15009034650190 CAPSULE in 1 BOTTLE (50090-3465-1) 90 capsule2018-06-120000-00-00NoNoCurrent