FDA.reportPublic FDA data

Omeprazole

Product NDC
57237-160
11-digit product format
572370160
Labeler code
57237
Product ID
57237-160_aec12e35-60fb-416c-a2d0-a87cfdcb30a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
Substance
OMEPRAZOLE
Active strength
10 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
OMEPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119, 200329

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-160-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10014
57237-160-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-160-01EA - Each57237-160f270ecf7-45fb-4f3f-b11d-b98be0dccd0512016-06-14
57237-160-30EA - Each57237-16049af8002-9882-45a2-a782-a94219ead67d12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-160OMEPRAZOLE CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]14Current NDC, Legacy NDC, 2 package rows20241115_a1b1c61b-d4fe-433d-ad31-0b11758976fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSNa1b1c61b-d4fe-433d-ad31-0b11758976fa14
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa1b1c61b-d4fe-433d-ad31-0b11758976fa14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNa1b1c61b-d4fe-433d-ad31-0b11758976fa14
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDa1b1c61b-d4fe-433d-ad31-0b11758976fa14
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa1b1c61b-d4fe-433d-ad31-0b11758976fa14
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDa1b1c61b-d4fe-433d-ad31-0b11758976fa14
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYa1b1c61b-d4fe-433d-ad31-0b11758976fa14
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa1b1c61b-d4fe-433d-ad31-0b11758976fa14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-160-0157237016001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-160-01) 2015-08-190000-00-00NoNoCurrent
57237-160-305723701603030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-160-30) 2015-08-190000-00-00NoNoCurrent