esomeprazole magnesium

Product NDC
69844-050
11-digit product format
698440050
Labeler code
69844
Product ID
69844-050_130aabb3-95f2-4a4e-8365-61bbb3e8436b
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA216349
Marketing category
ANDA
Marketing start
2022-06-24
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69844-050-01698440050011 BOTTLE in 1 CARTON (69844-050-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent
69844-050-02698440050022 BOTTLE in 1 CARTON (69844-050-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-06-240000-00-00NoNoCurrent
69844-050-03698440050033 BOTTLE in 1 CARTON (69844-050-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-06-240000-00-00NoNoCurrent