OMEPRAZOLE

Product NDC
70934-433
11-digit product format
709340433
Labeler code
70934
Product ID
70934-433_ad2da64a-1e3c-b557-e053-2995a90a4774
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA203481
Marketing category
ANDA
Marketing start
2019-08-26
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-433-147093404331414 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70934-433-14) 2019-08-280000-00-00NoNoCurrent
70934-433-307093404333030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70934-433-30) 2020-01-060000-00-00NoNoCurrent
70934-433-607093404336060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70934-433-60) 2019-08-260000-00-00NoNoCurrent
70934-433-907093404339090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70934-433-90) 2019-11-130000-00-00NoNoCurrent