Omeprazole and sodium bicarbonate

Product NDC
0363-0732
11-digit product format
003630732
Labeler code
0363
Product ID
0363-0732_418a1ab3-af9c-459d-b8b3-471788d50d8d
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole, sodium bicarbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA201361
Marketing category
ANDA
Marketing start
2016-07-15
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 1100 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], 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
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fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0732-01Omeprazole and sodium bicarbonate14 in 1 BOTTLECAPSULE, GELATIN COATED146
0363-0732-03Omeprazole and sodium bicarbonate3 in 1 CARTONCAPSULE, GELATIN COATED36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0732OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE, GELATIN COATED [WALGREEN COMPANY]5Current NDC, Legacy NDC, 2 package rows20230425_8753a131-f8b1-48e1-993b-73c1ee635fef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN8753a131-f8b1-48e1-993b-73c1ee635fef6
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD8753a131-f8b1-48e1-993b-73c1ee635fef6
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY8753a131-f8b1-48e1-993b-73c1ee635fef6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0732-010036307320114 in 1 BOTTLEHistorical
0363-0732-03003630732033 BOTTLE in 1 CARTON (0363-0732-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE (0363-0732-01) 3 bottle2016-07-150000-00-00NoNoCurrent