FDA.reportPublic FDA data

Signature Care Omeprazole

Product NDC
21130-137
11-digit product format
211300137
Labeler code
21130
Product ID
21130-137_fe806f67-4a8c-40ae-9750-d0c7a4a33aa6
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Safeway
Application
NDA022032
Marketing category
NDA
Marketing start
2015-09-18
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
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-137-30Signature Care Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
21130-137-30Signature Care Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE145
21130-137-55Signature Care Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE145
21130-137-55Signature Care Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
21130-137-74Signature Care Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE15
21130-137-74Signature Care Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE145

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9SIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9SIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UISIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-137SIGNATURE CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SAFEWAY]5Current NDC, Legacy NDC, 6 package rows20250213_6361a492-782f-4608-a20f-1bd86afbd864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN6361a492-782f-4608-a20f-1bd86afbd8645
402014omeprazole 20 MG Delayed Release Oral TabletSCD6361a492-782f-4608-a20f-1bd86afbd8645
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY6361a492-782f-4608-a20f-1bd86afbd8645

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-137-30211300137302 CARTON in 1 CARTON (21130-137-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2015-10-110000-00-00NoNoCurrent
21130-137-55211300137553 CARTON in 1 CARTON (21130-137-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2015-10-110000-00-00NoNoCurrent
21130-137-742113001377414 BLISTER PACK in 1 CARTON (21130-137-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2015-09-180000-00-00NoNoCurrent