FDA.reportPublic FDA data

Omeprazole, Sodium bicarbonate

Product NDC
63629-2491
11-digit product format
636292491
Labeler code
63629
Product ID
63629-2491_859fb23d-e8fd-4f0e-ba2b-a52ce839fb94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole, Sodium bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212587
Marketing category
ANDA
Marketing start
2021-05-11
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
UniiKG60484QX9, 8MDF5V39QO
Rxcui616541

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
63629-2491-1Omeprazole, Sodium bicarbonate30 in 1 BOTTLECAPSULE30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2491-1EA - Each63629-2491e9d2a7fd-ddd2-49b8-9b41-45b131ef275912021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2491OMEPRAZOLE, SODIUM BICARBONATE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20230223_8ab39749-8e9f-468b-be9b-bce630dbffde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSN8ab39749-8e9f-468b-be9b-bce630dbffde103
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD8ab39749-8e9f-468b-be9b-bce630dbffde103
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSY8ab39749-8e9f-468b-be9b-bce630dbffde103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2491-16362924910130 CAPSULE in 1 BOTTLE (63629-2491-1) 30 capsule2021-12-220000-00-00NoNoCurrent