FDA.reportPublic FDA data

Omeprazole

Product NDC
51655-893
11-digit product format
516550893
Labeler code
51655
Product ID
51655-893_4974171a-c249-7eab-e063-6294a90a6e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075757
Marketing category
ANDA
Marketing start
2022-08-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-893-25Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE603
51655-893-26Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE903
51655-893-83Omeprazole180 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE1803
51655-893-84Omeprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-893OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20240302_f76c23d5-26b6-cfb2-e053-6294a90aea42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNf76c23d5-26b6-cfb2-e053-6294a90aea423
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDf76c23d5-26b6-cfb2-e053-6294a90aea423
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYf76c23d5-26b6-cfb2-e053-6294a90aea423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-893-255165508932560 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-25) 2022-09-19NoNoCurrent
51655-893-265165508932690 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-26) 2022-08-23NoNoCurrent
51655-893-8351655089383180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-83) 2024-02-15NoNoCurrent
51655-893-845165508938414 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-893-84) 2022-09-19NoNoCurrent