FDA.reportPublic FDA data

NEXIUM

Product NDC
21695-091
11-digit product format
216950091
Labeler code
21695
Product ID
21695-091_ea79f802-e9ac-480b-91e6-1e3900b11803
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021153
Marketing category
NDA
Marketing start
2011-07-08
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-091-102019-09-24C16284748780-1934fe258-4c0b-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use NEXIUM safely and effectively. See full prescribing information for NEXIUM. NEXIUM (esomeprazole magnesium) DELAYED-RELEASE CAPSULES NEXIUM (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION Initial U.S. Approval: 1989 (omeprazole)
21695-091-302019-09-24C16284748780-1934fe258-4c0b-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use NEXIUM safely and effectively. See full prescribing information for NEXIUM. NEXIUM (esomeprazole magnesium) DELAYED-RELEASE CAPSULES NEXIUM (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION Initial U.S. Approval: 1989 (omeprazole)
21695-091-602019-09-24C16284748780-1934fe258-4c0b-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use NEXIUM safely and effectively. See full prescribing information for NEXIUM. NEXIUM (esomeprazole magnesium) DELAYED-RELEASE CAPSULES NEXIUM (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-091-10NEXIUM10 in 1 BOTTLECAPSULE, DELAYED RELEASE101
21695-091-30NEXIUM30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
21695-091-60NEXIUM60 in 1 BOTTLECAPSULE, DELAYED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-091-10EA - Each21695-0918365e3b7-bd2c-45fa-842a-19c748ddffc112012-07-24
21695-091-30EA - Each21695-09127a62e71-a812-49c6-bdde-1331890a792012012-07-24
21695-091-60EA - Each21695-091abf7a65c-be89-45e9-af6a-d2d0a8e0d78b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE MAGNESIUMACTIVE INGREDIENTR6DXU4WAY9NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-091NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20111216_ea79f802-e9ac-480b-91e6-1e3900b11803.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNea79f802-e9ac-480b-91e6-1e3900b118031
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNea79f802-e9ac-480b-91e6-1e3900b118031
606728NexIUM 20 MG Delayed Release Oral CapsulePSNea79f802-e9ac-480b-91e6-1e3900b118031
606731NexIUM 40 MG Delayed Release Oral CapsulePSNea79f802-e9ac-480b-91e6-1e3900b118031
606728esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]SBDea79f802-e9ac-480b-91e6-1e3900b118031
606731esomeprazole 40 MG Delayed Release Oral Capsule [Nexium]SBDea79f802-e9ac-480b-91e6-1e3900b118031
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDea79f802-e9ac-480b-91e6-1e3900b118031
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDea79f802-e9ac-480b-91e6-1e3900b118031
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606728Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606728Nexium 20 MG Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606728Nexium 24 HR 20 MG Delayed release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606731Nexium 40 MG (as esomeprazole magnesium trihydrate 44.5 MG) Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031
606731Nexium 40 MG Delayed Release Oral CapsuleSYea79f802-e9ac-480b-91e6-1e3900b118031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-091-102169500911010 in 1 BOTTLEHistorical
21695-091-302169500913030 in 1 BOTTLEHistorical
21695-091-602169500916060 in 1 BOTTLEHistorical