FDA.reportPublic FDA data

NEXIUM

Product NDC
0186-4040
11-digit product format
001864040
Labeler code
0186
Product ID
0186-4040_26f66e74-b652-4b1d-bfff-62a3cc87d590
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021957
Marketing category
NDA
Marketing start
2007-03-19
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], 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
NEXIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726, 606728, 606730, 606731, 692576, 692578, 861568, 861570, 861576, 861583, 1297658, 1297660, 1297761, 1297763

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0186-4040-01NEXIUM30 in 1 CARTONGRANULE, DELAYED RELEASE3074
0186-4040-02NEXIUM5 in 1 CARTONGRANULE, DELAYED RELEASE574

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0186-4040-01EA - Each0186-4040139f27b1-d6e5-4092-bef3-25fbf123332612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE MAGNESIUMACTIVE INGREDIENTR6DXU4WAY9NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
ALCOHOLINACTIVE INGREDIENT3K9958V90MNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
GELATININACTIVE INGREDIENT2G86QN327LNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
POVIDONESINACTIVE INGREDIENTFZ989GH94ENEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
TALCINACTIVE INGREDIENT7SEV7J4R1UNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41
WATERINACTIVE INGREDIENT059QF0KO0RNEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0186-4040NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]72Current NDC, Legacy NDC, 2 package rows20240628_f4853677-1622-4037-688b-fdf533a11d96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861568esomeprazole 10 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
1297658esomeprazole 2.5 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
1297761esomeprazole 5 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf4853677-1622-4037-688b-fdf533a11d9674
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf4853677-1622-4037-688b-fdf533a11d9674
861570NexIUM 10 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
1297660NexIUM 2.5 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
606728NexIUM 20 MG Delayed Release Oral CapsulePSNf4853677-1622-4037-688b-fdf533a11d9674
861576NexIUM 20 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
606731NexIUM 40 MG Delayed Release Oral CapsulePSNf4853677-1622-4037-688b-fdf533a11d9674
861583NexIUM 40 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
1297763NexIUM 5 MG Granules for Delayed Release Oral SuspensionPSNf4853677-1622-4037-688b-fdf533a11d9674
861570esomeprazole 10 MG Granules for Oral Suspension [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
1297660esomeprazole 2.5 MG Granules for Oral Suspension [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
606728esomeprazole 20 MG Delayed Release Oral Capsule [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
861576esomeprazole 20 MG Granules for Oral Suspension [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
606731esomeprazole 40 MG Delayed Release Oral Capsule [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
861583esomeprazole 40 MG Granules for Oral Suspension [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
1297763esomeprazole 5 MG Granules for Oral Suspension [Nexium]SBDf4853677-1622-4037-688b-fdf533a11d9674
861568esomeprazole 10 MG Granules for Oral SuspensionSCDf4853677-1622-4037-688b-fdf533a11d9674
1297658esomeprazole 2.5 MG Granules for Oral SuspensionSCDf4853677-1622-4037-688b-fdf533a11d9674
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf4853677-1622-4037-688b-fdf533a11d9674
692576esomeprazole 20 MG Granules for Oral SuspensionSCDf4853677-1622-4037-688b-fdf533a11d9674
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf4853677-1622-4037-688b-fdf533a11d9674
692578esomeprazole 40 MG Granules for Oral SuspensionSCDf4853677-1622-4037-688b-fdf533a11d9674
1297761esomeprazole 5 MG Granules for Oral SuspensionSCDf4853677-1622-4037-688b-fdf533a11d9674
1297658esomeprazole (as esomeprazole magnesium) 2.5 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
692576esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
861568esomeprazole 10 MG (equivalent to esomeprazole magnesium 11.1 MG) Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
861568esomeprazole 10 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
692578esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
1297761esomeprazole 5 MG (equivalent to esomeprazole magnesium 5.6 MG) Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
861570Nexium 10 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
1297660Nexium 2.5 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
606728Nexium 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
606728Nexium 20 MG Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
861576Nexium 20 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
606728Nexium 24 HR 20 MG Delayed release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
606731Nexium 40 MG (as esomeprazole magnesium trihydrate 44.5 MG) Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
606731Nexium 40 MG Delayed Release Oral CapsuleSYf4853677-1622-4037-688b-fdf533a11d9674
861583Nexium 40 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674
1297763Nexium 5 MG Granules for Delayed Release Oral SuspensionSYf4853677-1622-4037-688b-fdf533a11d9674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0186-4040-010018640400130 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-01) 2007-03-190000-00-00NoNoCurrent
0186-4040-02001864040025 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-02) 2007-03-190000-00-00NoNoCurrent