FDA.reportPublic FDA data

Omeprazole

Product NDC
71205-613
11-digit product format
712050613
Labeler code
71205
Product ID
71205-613_d870bdc1-5e26-4153-89e2-f629fef60ad0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212977
Marketing category
ANDA
Marketing start
2019-02-20
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-613-06Omeprazole6 in 1 BOTTLECAPSULE, DELAYED RELEASE64
71205-613-14Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
71205-613-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
71205-613-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE604
71205-613-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-613-06EA - Each71205-613c40810cb-90fe-4c20-846e-777d6d0edca712023-12-05
71205-613-14EA - Each71205-613dc1246fc-32cd-43d3-b2e1-63ba79c1583e12022-06-06
71205-613-30EA - Each71205-613520e0f9a-b4c3-40f7-bb89-95f9a8c016d412022-03-09
71205-613-60EA - Each71205-6139880e4b4-c362-442a-a74f-b008e9b6bd6b12023-08-08
71205-613-90EA - Each71205-613277a3bb6-c04c-45fb-9297-1ca7f999ac2212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-613OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20230819_13b379ef-7982-434d-9e6b-e01cd2b398d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN13b379ef-7982-434d-9e6b-e01cd2b398d24
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD13b379ef-7982-434d-9e6b-e01cd2b398d24
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY13b379ef-7982-434d-9e6b-e01cd2b398d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-613-06712050613066 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-06) 2023-08-14NoNoCurrent
71205-613-147120506131414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-14) 2022-03-070000-00-00NoNoCurrent
71205-613-307120506133030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-30) 2021-10-250000-00-00NoNoCurrent
71205-613-607120506136060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-60) 2021-10-250000-00-00NoNoCurrent
71205-613-907120506139090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-90) 2021-10-250000-00-00NoNoCurrent