FDA.reportPublic FDA data

Omeprazole

Product NDC
57237-161
11-digit product format
572370161
Labeler code
57237
Product ID
57237-161_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
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, 199119, 200329

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
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
57237-161-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10014
57237-161-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
57237-161-50Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50014
57237-161-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014
57237-161-99Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-161-01EA - Each57237-161203cf79d-2933-4626-a533-a9553d4c76f212016-06-14
57237-161-30EA - Each57237-161d64f2486-57d9-4fd0-8fb1-daa3cc51bfb712016-06-14
57237-161-90EA - Each57237-1612133e61f-d252-4752-92ae-cabaea4d576312017-07-07
57237-161-99EA - Each57237-1612b5a842f-883a-4f1e-8636-1a7af169516912016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-161OMEPRAZOLE 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
198051omeprazole 20 MG Delayed Release Oral CapsulePSN064b1418-0f42-4b18-9dee-cda40c5e1fca107
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD064b1418-0f42-4b18-9dee-cda40c5e1fca107
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY064b1418-0f42-4b18-9dee-cda40c5e1fca107
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
198051omeprazole 20 MG Delayed Release Oral CapsulePSN10a3fbc9-00c6-ad83-e063-6294a90ae1ad4
198051omeprazole 20 MG Delayed Release Oral CapsulePSNaf707c0a-5193-3f83-e053-2995a90a78ef4
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5048b657-38e4-22f7-e054-00144ff8d46c4
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDaf707c0a-5193-3f83-e053-2995a90a78ef4
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5048b657-38e4-22f7-e054-00144ff8d46c4
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD10a3fbc9-00c6-ad83-e063-6294a90ae1ad4
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5048b657-38e4-22f7-e054-00144ff8d46c4
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYaf707c0a-5193-3f83-e053-2995a90a78ef4
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY10a3fbc9-00c6-ad83-e063-6294a90ae1ad4
198051omeprazole 20 MG Delayed Release Oral CapsulePSN319d990e-161b-4c16-b026-f55c413c7e8f1
198051omeprazole 20 MG Delayed Release Oral CapsulePSN26a82fb0-7b6b-0839-e063-6394a90a93021
198051omeprazole 20 MG Delayed Release Oral CapsulePSN23a03524-a45b-ad06-e063-6394a90aec131
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD319d990e-161b-4c16-b026-f55c413c7e8f1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD26a82fb0-7b6b-0839-e063-6394a90a93021
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD23a03524-a45b-ad06-e063-6394a90aec131
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY319d990e-161b-4c16-b026-f55c413c7e8f1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY26a82fb0-7b6b-0839-e063-6394a90a93021
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY23a03524-a45b-ad06-e063-6394a90aec131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-161-0157237016101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-01) 2015-08-190000-00-00NoNoCurrent
57237-161-305723701613030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-30) 2015-08-190000-00-00NoNoCurrent
57237-161-5057237016150500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-50) 2015-08-190000-00-00NoNoCurrent
57237-161-905723701619090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90) 2015-08-190000-00-00NoNoCurrent
57237-161-99572370161991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-99) 2015-08-190000-00-00NoNoCurrent