Prilosec OTC

Product NDC
70518-2167
11-digit product format
705182167
Labeler code
70518
Product ID
70518-2167_dae52391-e956-e31a-e053-2995a90acb7e
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA021229
Marketing category
NDA
Marketing start
2019-06-28
Marketing end
0000-00-00
Substance
OMEPRAZOLE MAGNESIUM
Active strength
21 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2167-07051821670030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2167-0) 2019-06-280000-00-00NoNoCurrent