FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
27241-030
11-digit product format
272410030
Labeler code
27241
Product ID
27241-030_e627be01-7cc1-4a03-a183-1a5cfe92f9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA205545
Marketing category
ANDA
Marketing start
2016-07-27
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40; 1680 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole and Sodium Bicarbonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1
SODIUM BICARBONATE1680 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MDF5V39QO, KG60484QX9
Rxcui753557, 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
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
27241-030-31Omeprazole and Sodium Bicarbonate30 in 1 CARTONFOR SUSPENSION3014
27241-030-62Omeprazole and Sodium Bicarbonate1 in 1 PACKETFOR SUSPENSION114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-030OMEPRAZOLE AND SODIUM BICARBONATE FOR SUSPENSION [AJANTA PHARMA USA INC.]13Current NDC, Legacy NDC, 2 package rows20240911_bd84ca00-6352-4cb3-bce2-05f4a5005a94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYbd84ca00-6352-4cb3-bce2-05f4a5005a9414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-030-312724100303130 FOR SUSPENSION in 1 CARTON (27241-030-31) 30 for suspension2016-07-270000-00-00NoNoCurrent
27241-030-62272410030621 FOR SUSPENSION in 1 PACKET (27241-030-62) 1 for suspension2016-07-270000-00-00NoNoCurrent