Gengraf

Product NDC
0074-7269
11-digit product format
000747269
Labeler code
0074
Product ID
0074-7269_58130bbd-f2d6-4dc8-a4e1-d00fa272fe2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
SOLUTION
Route
ORAL
Labeler
AbbVie Inc.
Application
ANDA065025
Marketing category
ANDA
Marketing start
2010-05-25
Marketing end
0000-00-00
Substance
CYCLOSPORINE
Active strength
100 mg/mL
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-7269-50ML - Milliliter0074-72694d84d216-2d24-454e-b2d1-8c8671c52a3a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DGENGRAF (CYCLOSPORINE) SOLUTION [ABBVIE INC.]1207
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DGENGRAF (CYCLOSPORINE) SOLUTION [ABBVIE INC.]1207
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FGENGRAF (CYCLOSPORINE) SOLUTION [ABBVIE INC.]1207
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENGRAF (CYCLOSPORINE) SOLUTION [ABBVIE INC.]1207
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56GENGRAF (CYCLOSPORINE) SOLUTION [ABBVIE INC.]1207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7269GENGRAF (CYCLOSPORINE) SOLUTION [ABBVIE INC.]1237Legacy NDC20250214_29891f95-9079-4880-7abc-194e49767dd5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-7269-50000747269501 BOTTLE in 1 CARTON (0074-7269-50) > 50 mL in 1 BOTTLE1 bottle2010-05-250000-00-00NoNoCurrent