Omeprazole/Sodium Bicarbonate

Product NDC
63629-2243
11-digit product format
636292243
Labeler code
63629
Product ID
63629-2243_1704db40-ead8-4084-8b95-175a21a35a7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079182
Marketing category
ANDA
Marketing start
2016-07-18
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40 mg/1; mg/1
Pharmacologic classes
Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump 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
63629-2243-1EA - Each63629-22431b788137-7fb4-45d9-a23e-1863413e2fe812021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2243-16362922430130 PACKET in 1 CARTON (63629-2243-1) > 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2021-05-240000-00-00NoNoCurrent