Omeprazole/Sodiium Bicarbonate

Product NDC
72189-568
11-digit product format
721890568
Labeler code
72189
Product ID
72189-568_1f7f63c1-17c3-9a05-e063-6394a90abc6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole/Sodiium Bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_rx
Application
ANDA204228
Marketing category
ANDA
Marketing start
2024-08-12
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40; 1100 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
KG60484QX9OMEPRAZOLE73590-58-6OMEPRAZOLE
8MDF5V39QOSODIUM BICARBONATE144-55-8SODIUM BICARBONATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-568-307218905683030 CAPSULE in 1 BOTTLE (72189-568-30) 30 capsule2024-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Omeprazole/Sodiium BicarbonateDirect_rx2024-08-12HUMAN PRESCRIPTION DRUG LABEL1