FDA.reportPublic FDA data

Omeprazole

Product NDC
43063-743
11-digit product format
430630743
Labeler code
43063
Product ID
43063-743_414b3f69-cc8c-44cb-e063-6394a90a8d5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
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
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
43063-743-14Omeprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE1432
43063-743-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3032
43063-743-60Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE6032
43063-743-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE9032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-743-14EA - Each43063-743265b0416-3ba4-4995-b1dc-a43710e21eca12017-05-03
43063-743-30EA - Each43063-7433e66e43c-f40f-458f-879b-aa7b421e636212017-03-06
43063-743-60EA - Each43063-7439e0c2816-2765-4f41-820b-b55daaa5d75312017-05-03
43063-743-90EA - Each43063-743bf7d4445-f76b-49e8-a007-58cf629e663b12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-743OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 4 package rows20241228_e235ef89-3592-4ca1-8c13-d7ce84b1001c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNe235ef89-3592-4ca1-8c13-d7ce84b1001c32
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDe235ef89-3592-4ca1-8c13-d7ce84b1001c32
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYe235ef89-3592-4ca1-8c13-d7ce84b1001c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-743-144306307431414 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-14) 2017-03-240000-00-00NoNoCurrent
43063-743-304306307433030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-30) 2017-02-080000-00-00NoNoCurrent
43063-743-604306307436060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-60) 2017-03-240000-00-00NoNoCurrent
43063-743-904306307439090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-743-90) 2017-03-240000-00-00NoNoCurrent