FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-0569
11-digit product format
713350569
Labeler code
71335
Product ID
71335-0569_f5868802-1b1f-4d48-8793-39d25a65b0d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076048
Marketing category
ANDA
Marketing start
2003-11-11
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0569-0Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE75
71335-0569-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
71335-0569-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
71335-0569-3Omeprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE565
71335-0569-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
71335-0569-5Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
71335-0569-6Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE155
71335-0569-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1205
71335-0569-8Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1005
71335-0569-9Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0569-0EA - Each71335-0569d6e14194-6815-4e07-aed6-8a21560c19ef12018-03-08
71335-0569-1EA - Each71335-0569d7de20f0-48f8-401f-b22d-ff80022725b312018-03-08
71335-0569-2EA - Each71335-056948b3ffae-66a7-466e-853a-0f82195d00ac12018-03-08
71335-0569-3EA - Each71335-056927833085-064c-4bd1-9816-ada6d2e746cc12018-03-08
71335-0569-4EA - Each71335-0569c7c3e337-3b66-460b-a7fd-23eaf1a8126412018-03-08
71335-0569-5EA - Each71335-0569cfadd8f2-b3a9-45c1-a6e1-eea361ea6f0112018-03-08
71335-0569-6EA - Each71335-05694a28efde-3a4f-4ea6-879e-4fb33cf1c99f12018-03-08
71335-0569-7EA - Each71335-0569506ed262-ded8-4d4f-8d2d-a83cb73d302912018-03-08
71335-0569-8EA - Each71335-0569d9016da6-7793-4d8b-bdde-c7b618640ac612018-03-08
71335-0569-9EA - Each71335-0569052a96f1-73a6-4f9b-9a68-970c6d67ec2b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0569OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20241004_44349466-73ea-4053-8ff6-5b4b7372c9cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN44349466-73ea-4053-8ff6-5b4b7372c9cd5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD44349466-73ea-4053-8ff6-5b4b7372c9cd5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY44349466-73ea-4053-8ff6-5b4b7372c9cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0569-0713350569007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-0) 2006-06-262027-01-31NoNoCurrent
71335-0569-17133505690130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-1) 2006-06-262027-01-31NoNoCurrent
71335-0569-27133505690260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-2) 2006-06-262027-01-31NoNoCurrent
71335-0569-37133505690356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-3) 2006-06-262027-01-31NoNoCurrent
71335-0569-47133505690490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-4) 2006-06-262027-01-31NoNoCurrent
71335-0569-57133505690520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-5) 2006-06-262027-01-31NoNoCurrent
71335-0569-67133505690615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-6) 2006-06-262027-01-31NoNoCurrent
71335-0569-771335056907120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-7) 2006-06-262027-01-31NoNoCurrent
71335-0569-871335056908100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-8) 2006-06-262027-01-31NoNoCurrent
71335-0569-97133505690928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-9) 2006-06-262027-01-31NoNoCurrent