Acid Reducer

Product NDC
0363-1008
11-digit product format
003631008
Labeler code
0363
Product ID
0363-1008_f3c6b5e7-49d3-4c89-907f-782953c31b90
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA206877
Marketing category
ANDA
Marketing start
2021-05-06
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
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
Acid Reducer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1008-05Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145
0363-1008-05Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE15
0363-1008-61Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145
0363-1008-61Acid Reducer2 in 1 CARTONTABLET, DELAYED RELEASE25
0363-1008-62Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE35
0363-1008-62Acid Reducer14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1008ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [WALGREEN CO.]5Current NDC, Legacy NDC, 6 package rows20240618_b9561780-e358-b610-e053-2a95a90af020.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNb9561780-e358-b610-e053-2a95a90af0205
402014omeprazole 20 MG Delayed Release Oral TabletSCDb9561780-e358-b610-e053-2a95a90af0205
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYb9561780-e358-b610-e053-2a95a90af0205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1008-05003631008051 BOTTLE in 1 CARTON (0363-1008-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2021-05-060000-00-00NoNoCurrent
0363-1008-61003631008612 BOTTLE in 1 CARTON (0363-1008-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2021-05-060000-00-00NoNoCurrent
0363-1008-62003631008623 BOTTLE in 1 CARTON (0363-1008-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2021-05-060000-00-00NoNoCurrent