FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
50228-363
11-digit product format
502280363
Labeler code
50228
Product ID
50228-363_25403f99-6570-5b4b-e063-6294a90a9963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA207476
Marketing category
ANDA
Marketing start
2016-12-06
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 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

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 BICARBONATE1100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO, KG60484QX9
Rxcui616539, 616541

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
50228-363-05Omeprazole and Sodium Bicarbonate500 in 1 BOTTLECAPSULE5008
50228-363-30Omeprazole and Sodium Bicarbonate30 in 1 BOTTLECAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-363OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [SCIEGEN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20241027_a107804e-b308-4e79-9447-07d93016f70f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNa107804e-b308-4e79-9447-07d93016f70f8
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNa107804e-b308-4e79-9447-07d93016f70f8
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDa107804e-b308-4e79-9447-07d93016f70f8
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDa107804e-b308-4e79-9447-07d93016f70f8
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYa107804e-b308-4e79-9447-07d93016f70f8
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYa107804e-b308-4e79-9447-07d93016f70f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-363-0550228036305500 CAPSULE in 1 BOTTLE (50228-363-05) 500 capsule2016-12-060000-00-00NoNoCurrent
50228-363-305022803633030 CAPSULE in 1 BOTTLE (50228-363-30) 30 capsule2016-12-060000-00-00NoNoCurrent