Omeprazole

Product NDC
70934-335
11-digit product format
709340335
Labeler code
70934
Product ID
70934-335_b7b15df4-de8f-2f40-e053-2995a90a757d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA075757
Marketing category
ANDA
Marketing start
2019-04-12
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
70934-335-607093403356060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-335-60) 2019-05-230000-00-00NoNoCurrent
70934-335-907093403359090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-335-90) 2019-04-120000-00-00NoNoCurrent