FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
43598-010
11-digit product format
435980010
Labeler code
43598
Product ID
43598-010_dc9f1708-68a6-cb89-36c5-4e5fdb30100e
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

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
Rxcui753562

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-010OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC.,]4Current NDC20240727_c6b5f808-4a49-1303-9711-badb022ecd70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNc6b5f808-4a49-1303-9711-badb022ecd704
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDc6b5f808-4a49-1303-9711-badb022ecd704
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYc6b5f808-4a49-1303-9711-badb022ecd704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-010-01435980010011 PACKET in 1 CARTON (43598-010-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET1 packet2024-07-15NoNoCurrent
43598-010-144359800101414 PACKET in 1 CARTON (43598-010-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET14 packet2024-07-15NoNoCurrent
43598-010-284359800102828 PACKET in 1 CARTON (43598-010-28) / 1 POWDER, FOR SUSPENSION in 1 PACKET28 packet2024-07-15NoNoCurrent
43598-010-424359800104242 PACKET in 1 CARTON (43598-010-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET42 packet2024-07-15NoNoCurrent