FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
72162-1906
11-digit product format
721621906
Labeler code
72162
Product ID
72162-1906_0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole, sodium bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021636
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2004-06-15
Marketing end
2026-08-31
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole and Sodium Bicarbonate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1
SODIUM BICARBONATE1680 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9, 8MDF5V39QO
Rxcui753562

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
72162-1906-3Omeprazole and Sodium Bicarbonate1 in 1 PACKETPOWDER, FOR SUSPENSION1101
72162-1906-3Omeprazole and Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1906-3EA - Each72162-1906bdfb9044-ba14-48af-8569-dce5ff1e876b12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1906OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240323_0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSN0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95101
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCD0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95101
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSY0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72162-1906-37216219060330 PACKET in 1 CARTON (72162-1906-3) / 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2004-06-152026-08-31NoNoHistorical