FDA.reportPublic FDA data

Omeprazole/Bicarbonate

Product NDC
69367-195
11-digit product format
693670195
Labeler code
69367
Product ID
69367-195_affcd9b4-a7b0-43be-9e3c-1b82614c3b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA207476
Marketing category
ANDA
Marketing start
2018-07-27
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
69367-195-30Omeprazole/Bicarbonate30 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-195-30EA - Each69367-195f4c1b576-9384-4fa4-836c-a37139652c5f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-195OMEPRAZOLE/BICARBONATE (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [WESTMINSTER PHARMACEUTICALS, LLC]9Legacy NDC, 1 package rows20250515_d69c2f0f-4e8b-422a-8aaf-a825998b04e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN4d642036-7175-4f29-9f07-dbd282231d4a3
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSN4d642036-7175-4f29-9f07-dbd282231d4a3
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD4d642036-7175-4f29-9f07-dbd282231d4a3
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD4d642036-7175-4f29-9f07-dbd282231d4a3
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY4d642036-7175-4f29-9f07-dbd282231d4a3
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSY4d642036-7175-4f29-9f07-dbd282231d4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-195-306936701953030 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (69367-195-30) 2018-07-270000-00-00NoNoCurrent