FDA.reportPublic FDA data

DG health omperazole

Product NDC
55910-713
11-digit product format
559100713
Labeler code
55910
Product ID
55910-713_d1d7bb64-1c13-4d36-b761-01ac075da14a
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Dolgencorp Inc
Application
NDA209400
Marketing category
NDA
Marketing start
2018-06-26
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
DG health omperazole
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-713-30DG health omperazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D147
55910-713-30DG health omperazole2 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D27
55910-713-55DG health omperazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D147
55910-713-55DG health omperazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D37
55910-713-74DG health omperazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D147
55910-713-74DG health omperazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-713DG HEALTH OMPERAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [DOLGENCORP INC]7Current NDC, Legacy NDC, 6 package rows20250209_99fdfeed-6828-4bf6-bb81-cd29a4ec610b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN99fdfeed-6828-4bf6-bb81-cd29a4ec610b7
2003656omeprazole 20 MG Disintegrating Oral TabletSCD99fdfeed-6828-4bf6-bb81-cd29a4ec610b7
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY99fdfeed-6828-4bf6-bb81-cd29a4ec610b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-713-30559100713302 CARTON in 1 CARTON (55910-713-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK2 carton2018-06-280000-00-00NoNoCurrent
55910-713-55559100713553 CARTON in 1 CARTON (55910-713-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2020-03-180000-00-00NoNoCurrent
55910-713-745591007137414 BLISTER PACK in 1 CARTON (55910-713-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-06-260000-00-00NoNoCurrent