FDA.reportPublic FDA data

Omeprazole

Product NDC
55111-643
11-digit product format
551110643
Labeler code
55111
Product ID
55111-643_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
Substance
OMEPRAZOLE
Active strength
10 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
OMEPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119, 200329

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
55111-643-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10034
55111-643-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50034
55111-643-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3034
55111-643-78Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1034
55111-643-79Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-643OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]30Current NDC, Legacy NDC, 5 package rows20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
200329omeprazole 40 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY603d2d06-c5e8-4378-a422-8dca1a410af734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-643-0155111064301100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-01) 2026-03-090000-00-00NoNoCurrent
55111-643-0555111064305500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-05) 2014-03-010000-00-00NoNoCurrent
55111-643-305511106433030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-643-30) 2026-03-090000-00-00NoNoCurrent
55111-643-785511106437810 BLISTER PACK in 1 CARTON (55111-643-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-643-79) 10 blister pack2014-03-010000-00-00NoNoCurrent
55111-643-795511106437910 in 1 BLISTER PACKHistorical