FDA.reportPublic FDA data

Naproxen and esomeprazole magnesium

Product NDC
85509-1438
11-digit product format
855091438
Labeler code
85509
Product ID
85509-1438_4c25c053-eadd-e346-e063-6394a90afe42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen and esomeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA217738
Marketing category
ANDA
Marketing start
2023-10-11
Substance
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Active strength
20; 500 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], 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
Naproxen and esomeprazole magnesium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9, 57Y76R9ATQ
Rxcui994008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1438-1Naproxen and esomeprazole magnesium100 in 1 BOTTLETABLET, DELAYED RELEASE1001
85509-1438-3Naproxen and esomeprazole magnesium30 in 1 BOTTLETABLET, DELAYED RELEASE301
85509-1438-6Naproxen and esomeprazole magnesium60 in 1 BOTTLETABLET, DELAYED RELEASE601
85509-1438-9Naproxen and esomeprazole magnesium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1438-1EA - Each85509-14384f3708dc-ecfb-408b-b1dc-dcaaf5d8625712026-04-20
85509-1438-3EA - Each85509-14386bc8b8b4-9705-4a2d-b269-408b459c10d512026-04-20
85509-1438-6EA - Each85509-14384c7c450d-359c-4e15-a85f-79cb9c79a20912026-04-20
85509-1438-9EA - Each85509-1438eb7c1ff3-c208-4169-ad16-0b166c303a1212026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994008naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN4c25c106-b5ca-079f-e063-6394a90a49781
994008esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral TabletSCD4c25c106-b5ca-079f-e063-6394a90a49781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1438-185509143801100 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-1) 2026-03-03NoNoHistorical
85509-1438-38550914380330 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-3) 2026-03-03NoNoHistorical
85509-1438-68550914380660 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-6) 2026-03-03NoNoHistorical
85509-1438-98550914380990 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-9) 2026-03-03NoNoHistorical