FDA.reportPublic FDA data

COLCHICINE

Product NDC
31722-099
11-digit product format
317220099
Labeler code
31722
Product ID
31722-099_1d9751e6-7a6c-6828-e063-6394a90a7783
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLCHICINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217620
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
31722-099-01COLCHICINE100 in 1 BOTTLECAPSULE1001
31722-099-10COLCHICINE1000 in 1 BOTTLECAPSULE10001
31722-099-30COLCHICINE30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-099COLCHICINE (COLCHICINE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20240720_b280f0dc-b24c-4606-aaf4-0673070d5b64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSN472ec026-c755-ae02-e063-6394a90af0c63
1550940colchicine 0.6 MG Oral CapsuleSCD472ec026-c755-ae02-e063-6394a90af0c63
1550940colchicine 0.6 MG Oral CapsulePSNb280f0dc-b24c-4606-aaf4-0673070d5b641
1550940colchicine 0.6 MG Oral CapsuleSCDb280f0dc-b24c-4606-aaf4-0673070d5b641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-099-0131722009901100 CAPSULE in 1 BOTTLE (31722-099-01) 100 capsule2024-04-29NoNoCurrent
31722-099-10317220099101000 CAPSULE in 1 BOTTLE (31722-099-10) 1000 capsule2024-04-29NoNoCurrent
31722-099-303172200993030 CAPSULE in 1 BOTTLE (31722-099-30) 30 capsule2024-04-29NoNoCurrent