FDA.reportPublic FDA data

Omeprazole, Sodium bicarbonate

Product NDC
53041-663
11-digit product format
530410663
Labeler code
53041
Product ID
53041-663_27536955-37df-4dcc-ad75-2b364fe95460
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole, Sodium bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA212587
Marketing category
ANDA
Marketing start
2020-05-07
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, 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

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
53041-663-77Omeprazole, Sodium bicarbonate30 in 1 BOTTLECAPSULE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-663OMEPRAZOLE, SODIUM BICARBONATE CAPSULE [GUARDIAN DRUG COMPANY]6Current NDC, Legacy NDC, 1 package rows20221110_e5c6c2cf-fb3b-456a-a0a0-be396d6f8319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNe5c6c2cf-fb3b-456a-a0a0-be396d6f83196
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNe5c6c2cf-fb3b-456a-a0a0-be396d6f83196
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDe5c6c2cf-fb3b-456a-a0a0-be396d6f83196
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDe5c6c2cf-fb3b-456a-a0a0-be396d6f83196
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYe5c6c2cf-fb3b-456a-a0a0-be396d6f83196
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYe5c6c2cf-fb3b-456a-a0a0-be396d6f83196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-663-775304106637730 CAPSULE in 1 BOTTLE (53041-663-77) 30 capsule2020-05-070000-00-00NoNoCurrent