FDA.reportPublic FDA data

ESOMEPRAZOLE STRONTIUM

Product NDC
70849-200
11-digit product format
708490200
Labeler code
70849
Product ID
70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole strontium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
R2 Pharma, LLC
Application
NDA202342
Marketing category
NDA
Marketing start
2016-09-15
Substance
ESOMEPRAZOLE STRONTIUM
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
ESOMEPRAZOLE STRONTIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE STRONTIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC5N25H3803
Rxcui1810787, 1810789

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70849-200-30ESOMEPRAZOLE STRONTIUM30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70849-200-30EA - Each70849-200253bc690-6c1e-48df-a015-7ced264daf9f12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70849-200ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [R2 PHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20161102_3c916d32-f9e9-1d15-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810789esomeprazole strontium 24.65 MG Delayed Release Oral CapsulePSN3c916d32-f9e9-1d15-e054-00144ff88e882
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsulePSN3c916d32-f9e9-1d15-e054-00144ff88e882
1810789esomeprazole strontium 24.65 MG Delayed Release Oral CapsuleSCD3c916d32-f9e9-1d15-e054-00144ff88e882
1810787esomeprazole strontium 49.3 MG Delayed Release Oral CapsuleSCD3c916d32-f9e9-1d15-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70849-200-307084902003030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30) 2016-09-150000-00-00NoNoCurrent