FDA.reportPublic FDA data

Omeprazole

Product NDC
62135-530
11-digit product format
621350530
Labeler code
62135
Product ID
62135-530_46879e67-0bb9-93a7-e063-6294a90af37d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075410
Marketing category
ANDA
Marketing start
2003-09-03
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
Rxcui199119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-530-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
62135-530-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-530-30EA - Each62135-5306155305f-5252-4cb1-aabb-cb952ed5801212023-04-07
62135-530-90EA - Each62135-530c7296617-4ac6-4262-af7c-d783259c332d12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-530OMEPRAZOLE CAPSULE, DELAYED RELEASE [CHARTWELL RX, LLC]2Current NDC, 2 package rows20241025_10f5502a-2e63-4f2a-a3ba-ddc5bd403051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN10f5502a-2e63-4f2a-a3ba-ddc5bd4030513
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD10f5502a-2e63-4f2a-a3ba-ddc5bd4030513
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY10f5502a-2e63-4f2a-a3ba-ddc5bd4030513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-530-306213505303030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62135-530-30) 2023-03-16NoNoCurrent
62135-530-906213505309090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62135-530-90) 2023-03-16NoNoCurrent