Esomeprazole Magnesium

Product NDC
0093-6450
11-digit product format
000936450
Labeler code
0093
Product ID
0093-6450_02045561-4512-4c00-8c31-bd4b2de399a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078003
Marketing category
ANDA
Marketing start
2015-02-17
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
20 mg/1
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
0093-6450-56EA - Each0093-6450235119ea-db28-4116-8833-1ea072442f8312015-03-03
0093-6450-98EA - Each0093-6450cece9e62-1a72-4fe3-ba73-7d2ec817fbb312015-03-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-6450-560009364505630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-6450-56) 2015-02-170000-00-00NoNoCurrent
0093-6450-980009364509890 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-6450-98) 2015-02-170000-00-00NoNoCurrent