FDA.reportPublic FDA data

Omeprazole

Product NDC
57237-162
11-digit product format
572370162
Labeler code
57237
Product ID
57237-162_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
40 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
OMEPRAZOLE40 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-162-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10014
57237-162-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100014
57237-162-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
57237-162-50Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50014
57237-162-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-162-01EA - Each57237-1621effb314-abea-4243-bde5-6e640e91130c12016-06-14
57237-162-30EA - Each57237-162a7770088-d20b-4ae8-8e98-095edc7cb67112016-06-14
57237-162-50EA - Each57237-162a1c7e7d9-c812-4069-930a-f8c9b890963012021-10-08
57237-162-90EA - Each57237-16262c693ec-810f-4b78-b670-62f2c568c2ca12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-162OMEPRAZOLE CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]14Current NDC, Legacy NDC, 5 package rows20241115_a1b1c61b-d4fe-433d-ad31-0b11758976fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc311c1b9-8ec2-4ac0-baa2-a5063fba2d80108
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc311c1b9-8ec2-4ac0-baa2-a5063fba2d80108
200329omeprazole 40 MG Delayed Release Oral CapsulePSN40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67102
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67102
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
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf5dd5d63-1376-1ff7-e053-2a95a90a1d944
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf3038133-8bb2-044e-e053-2995a90a6e7d4
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf5dd5d63-1376-1ff7-e053-2a95a90a1d944
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf3038133-8bb2-044e-e053-2995a90a6e7d4
200329omeprazole 40 MG Delayed Release Oral CapsulePSNdf1a4294-3893-4a11-b4d5-f3536678087e3
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc1276463-7357-45b5-9f7e-8d3c4a550ff43
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDdf1a4294-3893-4a11-b4d5-f3536678087e3
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc1276463-7357-45b5-9f7e-8d3c4a550ff43
200329omeprazole 40 MG Delayed Release Oral CapsulePSNeec8b7d7-3d4f-6c83-e053-2995a90a70712
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDeec8b7d7-3d4f-6c83-e053-2995a90a70712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-162-0157237016201100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-162-01) 2015-08-190000-00-00NoNoCurrent
57237-162-10572370162101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-162-10) 2015-08-190000-00-00NoNoCurrent
57237-162-305723701623030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-162-30) 2015-08-190000-00-00NoNoCurrent
57237-162-5057237016250500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-162-50) 2015-08-190000-00-00NoNoCurrent
57237-162-905723701629090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-162-90) 2015-08-190000-00-00NoNoCurrent