Omeprazole

Product NDC
63187-787
11-digit product format
631870787
Labeler code
63187
Product ID
63187-787_83ca8d89-bbd6-4a72-aeb3-ac1b4f93cc88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
KG60484QX9OMEPRAZOLE73590-58-6OMEPRAZOLE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-787-306318707873030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-30) 2016-12-010000-00-00NoNoCurrent
63187-787-606318707876060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-60) 2016-12-010000-00-00NoNoCurrent
63187-787-7263187078772120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-72) 2016-12-010000-00-00NoNoCurrent
63187-787-7863187078778180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-78) 2016-12-010000-00-00NoNoCurrent
63187-787-906318707879090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-90) 2016-12-010000-00-00NoNoCurrent