FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
68682-104
11-digit product format
686820104
Labeler code
68682
Product ID
68682-104_342c0d17-867e-d8da-e063-6394a90a3151
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole, sodium bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA021849
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2006-02-27
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1
SODIUM BICARBONATE1100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO, KG60484QX9
Rxcui616539, 616541, 753557, 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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-104-30Omeprazole and Sodium Bicarbonate30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-104-30EA - Each68682-104734009f2-c8fc-4242-8cd4-d50fbe247f9812015-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-104OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [OCEANSIDE PHARMACEUTICALS]14Current NDC, Legacy NDC, 1 package rows20250504_c26b6893-8264-4d4a-ac7e-1ddda933451e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYc26b6893-8264-4d4a-ac7e-1ddda933451e14
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYc26b6893-8264-4d4a-ac7e-1ddda933451e14
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYc26b6893-8264-4d4a-ac7e-1ddda933451e14
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYc26b6893-8264-4d4a-ac7e-1ddda933451e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-104-306868201043030 CAPSULE in 1 BOTTLE (68682-104-30) 30 capsule2007-02-270000-00-00NoNoCurrent