FDA.reportPublic FDA data

Gloperba

Product NDC
72690-010
11-digit product format
726900010
Labeler code
72690
Product ID
72690-010_3a77b97f-df41-4712-9b4d-93a9fa64e3c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colchicine
Dosage form
SOLUTION
Route
ORAL
Labeler
ROMEG Therapeutics, LLC
Application
NDA210942
Marketing category
NDA
Marketing start
2019-08-01
Marketing end
0000-00-00
Substance
COLCHICINE
Active strength
1 mg/5mL
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
72690-010-052021-01-29C16284748780-1ba0f9c33-0fd0-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GLOPERBA ® safely and effectively. See full prescribing information for GLOPERBA ® . GLOPERBA ® (colchicine) Oral Solution Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72690-010-05Gloperba150 mL in 1 BOTTLE, PLASTICSOLUTION1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72690-010GLOPERBA (COLCHICINE) SOLUTION [ROMEG THERAPEUTICS, LLC]1Legacy NDC, 1 package rows20190801_6971137c-deef-4309-909e-552f1930999d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2118892colchicine 0.6 MG in 5 mL Oral SolutionPSN6971137c-deef-4309-909e-552f1930999d1
2180558Gloperba 0.6 MG in 5 mL Oral SolutionPSN6971137c-deef-4309-909e-552f1930999d1
2180558colchicine 0.12 MG/ML Oral Solution [Gloperba]SBD6971137c-deef-4309-909e-552f1930999d1
2118892colchicine 0.12 MG/ML Oral SolutionSCD6971137c-deef-4309-909e-552f1930999d1
2118892colchicine 0.6 MG per 5 mL Oral SolutionSY6971137c-deef-4309-909e-552f1930999d1
2180558Gloperba 0.12 MG/ML Oral SolutionSY6971137c-deef-4309-909e-552f1930999d1
2180558Gloperba 0.6 MG per 5 mL Oral SolutionSY6971137c-deef-4309-909e-552f1930999d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
72690-010-0572690001005150 mL in 1 BOTTLE, PLASTIC150 mlHistorical