FDA.reportPublic FDA data

Omeprazole

Product NDC
83209-150
11-digit product format
832090150
Labeler code
83209
Product ID
83209-150_1ab3d2c4-43c7-504d-e063-6394a90a9ba9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA212977
Marketing category
ANDA
Marketing start
2024-06-12
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
83209-150-05Omeprazole5 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE51
83209-150-06Omeprazole6 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE61
83209-150-10Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE101
83209-150-15Omeprazole15 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE151
83209-150-20Omeprazole20 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE201
83209-150-30Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN1ab3d84c-c563-6f04-e063-6394a90a34ff1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD1ab3d84c-c563-6f04-e063-6394a90a34ff1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY1ab3d84c-c563-6f04-e063-6394a90a34ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83209-150-05832090150055 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-05) 2024-06-12NoNoCurrent
83209-150-06832090150066 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-06) 2024-06-12NoNoCurrent
83209-150-108320901501010 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-10) 2024-06-12NoNoCurrent
83209-150-158320901501515 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-15) 2024-06-12NoNoCurrent
83209-150-208320901502020 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-20) 2024-06-12NoNoCurrent
83209-150-308320901503030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (83209-150-30) 2024-06-12NoNoCurrent