Omeprazole and Sodium Bicarbonate

Product NDC
75907-138
11-digit product format
759070138
Labeler code
75907
Product ID
75907-138_3ccc6e19-1da7-caa1-2b51-6946e92a1a79
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.,
Application
ANDA217784
Marketing category
ANDA
Marketing start
2024-07-15
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 1680 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
75907-138-427590701384242 PACKET in 1 CARTON (75907-138-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET42 packet2024-07-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsDr. Reddy's Laboratories Inc.,2024-07-15HUMAN OTC DRUG LABEL1