FDA.reportPublic FDA data

Signature Care Omeprazole

Product NDC
21130-128
11-digit product format
211300128
Labeler code
21130
Product ID
21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Safeway
Application
NDA209400
Marketing category
NDA
Marketing start
2018-07-11
Substance
OMEPRAZOLE
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
Signature Care Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui2003656

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
21130-128-55Signature Care Omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D35
21130-128-55Signature Care Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145
21130-128-74Signature Care Omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D15
21130-128-74Signature Care Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-128SIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [SAFEWAY]5Current NDC, Legacy NDC, 4 package rows20250406_c76c4235-92d4-4384-8ddc-ceed0b928c48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSNc76c4235-92d4-4384-8ddc-ceed0b928c485
2003656omeprazole 20 MG Disintegrating Oral TabletSCDc76c4235-92d4-4384-8ddc-ceed0b928c485
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSYc76c4235-92d4-4384-8ddc-ceed0b928c485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-128-55211300128553 CARTON in 1 CARTON (21130-128-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-07-110000-00-00NoNoCurrent
21130-128-742113001287414 BLISTER PACK in 1 CARTON (21130-128-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2020-07-020000-00-00NoNoCurrent