Omeprazole/Bicarbonate

Product NDC
42291-585
11-digit product format
422910585
Labeler code
42291
Product ID
42291-585_d57df893-46e8-5689-e053-2995a90a42a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA207476
Marketing category
ANDA
Marketing start
2019-03-15
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40 mg/1; mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-585-30EA - Each42291-58592e36d72-52e8-467c-b76e-0730c69f55db12019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-585-304229105853030 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-585-30) 2019-03-150000-00-00NoNoCurrent