ONGLYZA

Product NDC
0310-6105
11-digit product format
003106105
Labeler code
0310
Product ID
0310-6105_faa525bd-c66c-4c61-8edb-d5985e388d63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SAXAGLIPTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022350
Marketing category
NDA
Marketing start
2014-11-20
Marketing end
0000-00-00
Substance
SAXAGLIPTIN HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6105-30EA - Each0310-61056dd7da80-25b6-4adb-898a-7ac6d7b9fc7c12015-01-05
0310-6105-50EA - Each0310-61056ec29721-4249-495a-9fc9-191b4033cd7b12015-01-05
0310-6105-90EA - Each0310-6105802599a2-1723-4cdf-ad96-e47a5711806a12015-01-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6105ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]26Legacy NDC20241019_c5116390-e0fe-4969-94cb-e9de5165fbab.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6105-300031061053030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30) 2014-12-180000-00-00NoNoCurrent
0310-6105-900031061059090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90) 2014-12-190000-00-00NoNoCurrent
0310-6105-95003106105951 BLISTER PACK in 1 CARTON (0310-6105-95) > 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-08-150000-00-00NoNoCurrent