FDA.reportPublic FDA data

OMEPRAZOLE AND SODIUM BICARBONATE

Product NDC
58602-725
11-digit product format
586020725
Labeler code
58602
Product ID
58602-725_48c99760-39f6-4e1f-ae95-16a52fc10898
Type
HUMAN OTC DRUG
Nonproprietary name
OMEPRAZOLE AND SODIUM BICARBONATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA204923
Marketing category
ANDA
Marketing start
2023-12-22
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
UniiKG60484QX9, 8MDF5V39QO
Rxcui616539

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
58602-725-05OMEPRAZOLE AND SODIUM BICARBONATE14 in 1 BOTTLECAPSULE142
58602-725-05OMEPRAZOLE AND SODIUM BICARBONATE1 in 1 CARTONCAPSULE12
58602-725-57OMEPRAZOLE AND SODIUM BICARBONATE2 in 1 CARTONCAPSULE22
58602-725-57OMEPRAZOLE AND SODIUM BICARBONATE14 in 1 BOTTLECAPSULE142
58602-725-60OMEPRAZOLE AND SODIUM BICARBONATE14 in 1 BOTTLECAPSULE142
58602-725-60OMEPRAZOLE AND SODIUM BICARBONATE3 in 1 CARTONCAPSULE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-725OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROHEALTH LLC]1Current NDC, 6 package rows20240630_88ad2e92-2228-49b2-bcee-1770fd30cb14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN88ad2e92-2228-49b2-bcee-1770fd30cb142
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD88ad2e92-2228-49b2-bcee-1770fd30cb142
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY88ad2e92-2228-49b2-bcee-1770fd30cb142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-725-05586020725051 BOTTLE in 1 CARTON (58602-725-05) / 14 CAPSULE in 1 BOTTLE1 bottle2023-12-22NoNoHistorical
58602-725-57586020725572 BOTTLE in 1 CARTON (58602-725-57) / 14 CAPSULE in 1 BOTTLE2 bottle2023-12-22NoNoHistorical
58602-725-60586020725603 BOTTLE in 1 CARTON (58602-725-60) / 14 CAPSULE in 1 BOTTLE3 bottle2023-12-22NoNoHistorical