FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-7366
11-digit product format
500907366
Labeler code
50090
Product ID
50090-7366_a3b97bb6-22dc-4ee0-b38e-da46398a51f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui200329

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7366-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
50090-7366-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
50090-7366-2Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903
50090-7366-3Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7366-0EA - Each50090-7366d4b72a9a-7e63-463e-a7bc-e5e3a60aba5e12024-12-10
50090-7366-1EA - Each50090-736699ac6ad3-a662-4f9d-8034-27cc5dab614f12024-12-10
50090-7366-2EA - Each50090-7366d80be56c-576e-40ef-a546-d917f12ce7df12024-12-10
50090-7366-3EA - Each50090-73661563800a-c2aa-4830-b534-6a1caefa49a512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7366OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20241024_c1276463-7357-45b5-9f7e-8d3c4a550ff4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc1276463-7357-45b5-9f7e-8d3c4a550ff43
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc1276463-7357-45b5-9f7e-8d3c4a550ff43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7366-05009073660030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-0) 2024-10-18NoNoHistorical
50090-7366-15009073660160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-1) 2024-10-18NoNoHistorical
50090-7366-25009073660290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-2) 2024-10-18NoNoHistorical
50090-7366-35009073660328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-3) 2024-10-18NoNoHistorical