Esomeprazole Sodium

Product NDC
17478-850
11-digit product format
174780850
Labeler code
17478
Product ID
17478-850_c4d77d0f-c98a-4644-a8a3-6e4cfe8b0ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akorn
Application
ANDA207181
Marketing category
ANDA
Marketing start
2017-03-06
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE SODIUM
Active strength
40 mg/5mL
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump 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
17478-850-10EA - Each17478-8506c880531-59ca-4f21-8591-f43d39cb47d412017-05-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-850-101747808501010 VIAL, SINGLE-DOSE in 1 CARTON (17478-850-10) > 5 mL in 1 VIAL, SINGLE-DOSE2017-03-060000-00-00NoNoCurrent