FDA.reportPublic FDA data

Omeprazole

Product NDC
68001-441
11-digit product format
680010441
Labeler code
68001
Product ID
68001-441_0486dc89-1bf1-8e37-e063-6394a90a9aa7
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207740
Marketing category
ANDA
Marketing start
2020-06-19
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
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-441-39Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
68001-441-40Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
68001-441-55Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
68001-441-98Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-441-39EA - Each68001-441b9f2615f-136c-48a3-8d62-89c8aec834d812020-09-14
68001-441-40EA - Each68001-441bddc9777-1448-465c-9d50-440abcb9523112020-09-14
68001-441-55EA - Each68001-4410720290b-f2aa-41e2-9b89-667f6bda486112022-06-06
68001-441-98EA - Each68001-441ea82b9cb-7b5a-43b5-a198-60bcb9e85c0212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-441OMEPRAZOLE TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]5Current NDC, Legacy NDC, 4 package rows20230914_a86d52a5-15e2-012d-e053-2a95a90ac912.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNa86d52a5-15e2-012d-e053-2a95a90ac9125
402014omeprazole 20 MG Delayed Release Oral TabletSCDa86d52a5-15e2-012d-e053-2a95a90ac9125
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYa86d52a5-15e2-012d-e053-2a95a90ac9125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-441-39680010441392 BOTTLE in 1 CARTON (68001-441-39) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 2 bottle2020-06-190000-00-00NoNoCurrent
68001-441-40680010441403 BOTTLE in 1 CARTON (68001-441-40) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 3 bottle2020-06-190000-00-00NoNoCurrent
68001-441-556800104415514 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 2020-06-190000-00-00NoNoCurrent
68001-441-98680010441981 BOTTLE in 1 CARTON (68001-441-98) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-441-55) 1 bottle2020-06-190000-00-00NoNoCurrent