FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-5901
11-digit product format
500905901
Labeler code
50090
Product ID
50090-5901_83204a11-3cda-4a40-96f7-5dc3907310e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212977
Marketing category
ANDA
Marketing start
2019-02-20
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
Rxcui198051

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5901-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
50090-5901-2Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE155
50090-5901-3Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
50090-5901-4Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
50090-5901-5Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
50090-5901-6Omeprazole200 in 1 BOTTLECAPSULE, DELAYED RELEASE2005
50090-5901-7Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1805
50090-5901-8Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5901-0EA - Each50090-590135ed557c-5e14-47c4-9463-c6b23d55f72d12022-06-06
50090-5901-2EA - Each50090-5901fe9a2dc0-55e3-4b5a-b2b7-c4ef2f64012c12022-06-06
50090-5901-3EA - Each50090-5901f5f87219-197c-445e-beda-feb7eec5458f12022-06-06
50090-5901-4EA - Each50090-59019a255aff-51bc-4bab-8a23-05cb033b19a512022-06-06
50090-5901-5EA - Each50090-5901a271c011-69f8-4122-9d5e-8b860f428d7f12022-06-06
50090-5901-6EA - Each50090-59018193a30f-586c-49c8-82f5-049f814d094e12022-06-06
50090-5901-7EA - Each50090-59017632a720-0655-4e10-bf87-d120ebeb9f7512022-06-06
50090-5901-8EA - Each50090-5901eaea8505-37e0-477b-9d1c-61826c6ac28f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5901OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 8 package rows20240103_6ea9a6f3-b756-4cdf-b3db-f666a2c17d66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN6ea9a6f3-b756-4cdf-b3db-f666a2c17d665
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD6ea9a6f3-b756-4cdf-b3db-f666a2c17d665
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY6ea9a6f3-b756-4cdf-b3db-f666a2c17d665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5901-05009059010030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-0) 2022-01-130000-00-00NoNoCurrent
50090-5901-25009059010215 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-2) 2022-01-210000-00-00NoNoCurrent
50090-5901-35009059010360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-3) 2022-01-210000-00-00NoNoCurrent
50090-5901-45009059010420 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-4) 2022-01-210000-00-00NoNoCurrent
50090-5901-55009059010590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-5) 2022-01-210000-00-00NoNoCurrent
50090-5901-650090590106200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-6) 2022-01-210000-00-00NoNoCurrent
50090-5901-750090590107180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-7) 2022-01-210000-00-00NoNoCurrent
50090-5901-8500905901087 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-8) 2022-01-210000-00-00NoNoCurrent