FDA.reportPublic FDA data

Colchicine

Product NDC
31722-899
11-digit product format
317220899
Labeler code
31722
Product ID
31722-899_c9c0c7c1-6f07-596e-e053-2995a90aae1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA208993
Marketing category
ANDA
Marketing start
2021-08-13
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
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
31722-899-01Colchicine100 in 1 BOTTLETABLET, FILM COATED1001
31722-899-30Colchicine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-899-01EA - Each31722-899da1ced6e-9f91-4efe-80f3-54aa0053142912022-02-07
31722-899-30EA - Each31722-89968086cc2-280b-43fb-bd10-961395a84e5712022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-899COLCHICINE (COLCHICINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20210818_1e7ef16d-262b-4dc0-92d6-7afe4aa21ebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN5cefec2e-1982-4417-8d99-5711231b3933101
197541colchicine 0.6 MG Oral TabletSCD5cefec2e-1982-4417-8d99-5711231b3933101
197541colchicine 600 MCG Oral TabletSY5cefec2e-1982-4417-8d99-5711231b3933101
197541colchicine 0.6 MG Oral TabletPSN68d4bf2b-8e2c-4621-aa08-463f43e253c32
197541colchicine 0.6 MG Oral TabletSCD68d4bf2b-8e2c-4621-aa08-463f43e253c32
197541colchicine 600 MCG Oral TabletSY68d4bf2b-8e2c-4621-aa08-463f43e253c32
197541colchicine 0.6 MG Oral TabletPSN1e7ef16d-262b-4dc0-92d6-7afe4aa21ebd1
197541colchicine 0.6 MG Oral TabletSCD1e7ef16d-262b-4dc0-92d6-7afe4aa21ebd1
197541colchicine 600 MCG Oral TabletSY1e7ef16d-262b-4dc0-92d6-7afe4aa21ebd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-899-0131722089901100 TABLET, FILM COATED in 1 BOTTLE (31722-899-01) 2021-08-130000-00-00NoNoCurrent
31722-899-303172208993030 TABLET, FILM COATED in 1 BOTTLE (31722-899-30) 2021-08-130000-00-00NoNoCurrent