FDA.reportPublic FDA data

Omeprazole

Product NDC
71205-907
11-digit product format
712050907
Labeler code
71205
Product ID
71205-907_f9c7393f-d347-4ae3-8771-8a3e3615510c
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
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
71205-907-00Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1002
71205-907-11Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10002
71205-907-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71205-907-55Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE5002
71205-907-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71205-907-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-907-00EA - Each71205-9070637cca1-02fc-4477-a297-f84a78a3a2aa12021-08-05
71205-907-11EA - Each71205-907e712ca12-a662-4a80-9b5f-f0e6385b766a12021-08-05
71205-907-30EA - Each71205-90700d9608d-67e6-4fa5-8f45-c3a87e20cb4e12021-08-05
71205-907-55EA - Each71205-9075d3ae405-448f-4f27-8935-8a2a39dae85e12021-08-05
71205-907-60EA - Each71205-9078d59c4cb-7d9e-4311-8e9e-343e41537fea12021-08-05
71205-907-90EA - Each71205-907ea54decf-9514-42ad-b3ff-e459d3a1740c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-907OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220419_2fc5065c-5850-469b-b357-fa4df30a8f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN2fc5065c-5850-469b-b357-fa4df30a8f782
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD2fc5065c-5850-469b-b357-fa4df30a8f782
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY2fc5065c-5850-469b-b357-fa4df30a8f782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-907-0071205090700100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-00) 2021-07-190000-00-00NoNoCurrent
71205-907-11712050907111000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-11) 2021-07-190000-00-00NoNoCurrent
71205-907-307120509073030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-30) 2021-07-190000-00-00NoNoCurrent
71205-907-5571205090755500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-55) 2021-07-190000-00-00NoNoCurrent
71205-907-607120509076060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-60) 2021-07-190000-00-00NoNoCurrent
71205-907-907120509079090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-90) 2021-07-190000-00-00NoNoCurrent