FDA.reportPublic FDA data

Omeprazole

Product NDC
63548-8040
11-digit product format
635488040
Labeler code
63548
Product ID
63548-8040_3d089928-8a08-4685-9a78-969c99edd5c1
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application
ANDA206582
Marketing category
ANDA
Marketing start
2024-10-31
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20.6 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
OMEPRAZOLE MAGNESIUM20.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63548-8040-2Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12
63548-8040-2Omeprazole42 in 1 CARTONTABLET, DELAYED RELEASE422
63548-8040-4Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12
63548-8040-4Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE142
63548-8040-8Omeprazole28 in 1 CARTONTABLET, DELAYED RELEASE282
63548-8040-8Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-8040OMEPRAZOLE TABLET, DELAYED RELEASE [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]2Current NDC, 6 package rows20241101_e67bf2c6-0618-48e0-aa08-705501d86431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNe67bf2c6-0618-48e0-aa08-705501d864312
402014omeprazole 20 MG Delayed Release Oral TabletSCDe67bf2c6-0618-48e0-aa08-705501d864312
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYe67bf2c6-0618-48e0-aa08-705501d864312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63548-8040-26354880400242 BLISTER PACK in 1 CARTON (63548-8040-2) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK42 blister pack2024-10-31NoNoCurrent
63548-8040-46354880400414 BLISTER PACK in 1 CARTON (63548-8040-4) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2024-10-31NoNoCurrent
63548-8040-86354880400828 BLISTER PACK in 1 CARTON (63548-8040-8) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK28 blister pack2024-10-31NoNoCurrent