FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
70954-797
11-digit product format
709540797
Labeler code
70954
Product ID
70954-797_63c3bd6c-a586-4ec0-8f45-ed936936dfeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA219161
Marketing category
ANDA
Marketing start
2026-01-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole and Sodium Bicarbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1
SODIUM BICARBONATE1680 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO, KG60484QX9
Rxcui753557, 753562

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-797-10Omeprazole and Sodium Bicarbonate1 in 1 PACKETPOWDER, FOR SUSPENSION11
70954-797-20Omeprazole and Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-797-10EA - Each70954-7975a456704-eed9-4596-ad67-0e357b0a01c412026-01-08
70954-797-20EA - Each70954-79777c3c9df-bd7f-40d7-97dd-3c05815b1ded12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSN63c3bd6c-a586-4ec0-8f45-ed936936dfeb1
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSN63c3bd6c-a586-4ec0-8f45-ed936936dfeb1
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCD63c3bd6c-a586-4ec0-8f45-ed936936dfeb1
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCD63c3bd6c-a586-4ec0-8f45-ed936936dfeb1
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSY63c3bd6c-a586-4ec0-8f45-ed936936dfeb1
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSY63c3bd6c-a586-4ec0-8f45-ed936936dfeb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-797-10709540797101 in 1 PACKETHistorical
70954-797-207095407972030 PACKET in 1 CARTON (70954-797-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-797-10) 30 packet2026-01-15NoNoHistorical