Omeprazole

Product NDC
43063-451
11-digit product format
430630451
Labeler code
43063
Product ID
43063-451_c977585d-4773-10e7-e053-2995a90ac3a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076048
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-451-904306304519090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-451-90) 2013-05-150000-00-00NoNoCurrent