FDA.reportPublic FDA data

Omeprazole/Sodium Bicarbonate

Product NDC
64380-183
11-digit product format
643800183
Labeler code
64380
Product ID
64380-183_2ac68a93-2f3b-46aa-a874-c109ad1bfefe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA079182
Marketing category
ANDA
Marketing start
2022-10-01
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40; 1680 mg/1720mg; mg/1720mg
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/1720mg
SODIUM BICARBONATE1680 mg/1720mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9, 8MDF5V39QO
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-183-01Omeprazole/Sodium Bicarbonate40 mg in 1 POUCHPOWDER, FOR SUSPENSION405
64380-183-02Omeprazole/Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-183-01EA - Each64380-183f6246d20-69dd-4f96-9782-65b665abdd6b12022-10-06
64380-183-02EA - Each64380-18375800e56-f451-4f5e-aa6c-bccf375f52d112022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-183OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE) POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, Legacy NDC, 2 package rows20231213_cf6d293e-d70d-443e-8292-d693e93aab55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNcf6d293e-d70d-443e-8292-d693e93aab555
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNcf6d293e-d70d-443e-8292-d693e93aab555
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDcf6d293e-d70d-443e-8292-d693e93aab555
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDcf6d293e-d70d-443e-8292-d693e93aab555
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYcf6d293e-d70d-443e-8292-d693e93aab555
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYcf6d293e-d70d-443e-8292-d693e93aab555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-183-016438001830140 mg in 1 POUCH40 mgHistorical
64380-183-026438001830230 POUCH in 1 CARTON (64380-183-02) / 40 mg in 1 POUCH (64380-183-01) 30 pouch2022-10-010000-00-00NoNoCurrent