BYDUREON

Product NDC
0310-6530
11-digit product format
003106530
Labeler code
0310
Product ID
0310-6530_c9d94096-3a71-4708-97e1-ae0b9a31c681
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
exenatide
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022200
Marketing category
NDA
Marketing start
2014-09-08
Marketing end
2023-04-30
Substance
EXENATIDE
Active strength
2 mg/.65mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6530-01EA - Each0310-653014a3f526-e40a-457a-bcec-965506484bc312019-04-11
0310-6530-04EA - Each0310-6530ef52efa2-1bc2-4a40-9799-3f3e30e3ce2212014-10-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6530-01003106530011 CARTRIDGE in 1 TRAY (0310-6530-01) > .65 mL in 1 CARTRIDGE1 cartridge2014-09-080000-00-00NoNoCurrent
0310-6530-04003106530041 TRAY in 1 CARTON (0310-6530-04) > 4 CARTRIDGE in 1 TRAY > .65 mL in 1 CARTRIDGE1 tray2014-09-080000-00-00NoNoCurrent