Omeprazole

Product NDC
69842-791
11-digit product format
698420791
Labeler code
69842
Product ID
69842-791_21aa099b-aabb-40ee-bbea-9db44c62e1e8
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
NDA209400
Marketing category
NDA
Marketing start
2018-02-27
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-791-55Omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D34
69842-791-55Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144
69842-791-74Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144
69842-791-74Omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-791-55EA - Each69842-7919006b87b-ca93-413e-95cc-6bf35716c6a512019-11-12
69842-791-74EA - Each69842-791f7d31093-35c0-4531-b7c9-6fc1868fc09d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-791OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CVS PHARMACY]4Current NDC, Legacy NDC, 4 package rows20250309_01bde9ca-0114-426d-8188-c55aefaa0961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN01bde9ca-0114-426d-8188-c55aefaa09614
2003656omeprazole 20 MG Disintegrating Oral TabletSCD01bde9ca-0114-426d-8188-c55aefaa09614
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY01bde9ca-0114-426d-8188-c55aefaa09614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-791-55698420791553 CARTON in 1 CARTON (69842-791-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-02-270000-00-00NoNoCurrent
69842-791-746984207917414 BLISTER PACK in 1 CARTON (69842-791-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-03-010000-00-00NoNoCurrent