FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-0332
11-digit product format
713350332
Labeler code
71335
Product ID
71335-0332_a400ebb3-e9ae-4db8-90b1-da9a9527230e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
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
Rxcui198051

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
71335-0332-0Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE77
71335-0332-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
71335-0332-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE607
71335-0332-3Omeprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE567
71335-0332-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907
71335-0332-5Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE207
71335-0332-6Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE157
71335-0332-7Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1207
71335-0332-8Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1007
71335-0332-9Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0332-0EA - Each71335-03320c8de6cd-a1e5-4053-a65c-8f9dc36463ca12018-01-12
71335-0332-1EA - Each71335-0332e22d4537-9902-4435-9f2e-ff80e73c046412018-01-12
71335-0332-2EA - Each71335-0332a89f8f82-0b8d-413b-a23a-ba690e7e790a12018-01-12
71335-0332-3EA - Each71335-03324d1dbe5d-c4cc-4b26-8c50-4dc6f1d8240212018-01-12
71335-0332-4EA - Each71335-03325102017d-6f28-4076-be94-f23df1d99e5412018-01-12
71335-0332-5EA - Each71335-0332a531b73f-a322-441f-8c8e-b2aac62633cb12018-01-12
71335-0332-6EA - Each71335-0332e99e22f6-f15b-4fb7-a464-48be6f24e31612018-01-12
71335-0332-7EA - Each71335-03326368c24e-d598-4b36-a378-f17c253802f012018-01-12
71335-0332-8EA - Each71335-0332a6b89f12-0571-4287-993e-122ce39b8d9912018-01-12
71335-0332-9EA - Each71335-0332130c2fc6-d616-4a2c-87d7-0629b2015ba112018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0332OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240530_e1f20429-cfaa-420b-a65a-271be37eb799.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNe1f20429-cfaa-420b-a65a-271be37eb7997
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDe1f20429-cfaa-420b-a65a-271be37eb7997
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYe1f20429-cfaa-420b-a65a-271be37eb7997

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0332-0713350332007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-0) 2024-05-280000-00-00NoNoCurrent
71335-0332-17133503320130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-1) 2018-07-160000-00-00NoNoCurrent
71335-0332-27133503320260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-2) 2020-03-250000-00-00NoNoCurrent
71335-0332-37133503320356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-3) 2024-05-280000-00-00NoNoCurrent
71335-0332-47133503320490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-4) 2020-05-080000-00-00NoNoCurrent
71335-0332-57133503320520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-5) 2020-06-030000-00-00NoNoCurrent
71335-0332-67133503320615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-6) 2018-07-060000-00-00NoNoCurrent
71335-0332-771335033207120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-7) 2020-03-120000-00-00NoNoCurrent
71335-0332-871335033208100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-8) 2024-05-280000-00-00NoNoCurrent
71335-0332-97133503320928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0332-9) 2024-05-280000-00-00NoNoCurrent