FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
0093-6451
11-digit product format
000936451
Labeler code
0093
Product ID
0093-6451_02045561-4512-4c00-8c31-bd4b2de399a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078003
Marketing category
ANDA
Marketing start
2015-02-17
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-6451-56EA - Each0093-64514e12f6e2-d2bc-451a-95c2-d807698d58b912015-03-03
0093-6451-98EA - Each0093-6451395d2d49-eb01-48a6-b11e-10b384a3a9b712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESOMEPRAZOLE MAGNESIUM DIHYDRATEACTIVE INGREDIENT36H71644EQESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
ESOMEPRAZOLE MAGNESIUM DIHYDRATEACTIVE INGREDIENT36H71644EQESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
ESOMEPRAZOLEACTIVE MOIETYN3PA6559FTESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
SUCROSEINACTIVE INGREDIENTC151H8M554ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
SUCROSEINACTIVE INGREDIENTC151H8M554ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DIRECT RX]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNb846b3ca-231c-4a95-b028-136c5107fa573
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDb846b3ca-231c-4a95-b028-136c5107fa573
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYb846b3ca-231c-4a95-b028-136c5107fa573
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN1f0ba9c8-e5f2-4d65-a0e3-19a6541a03b52
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD1f0ba9c8-e5f2-4d65-a0e3-19a6541a03b52
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY1f0ba9c8-e5f2-4d65-a0e3-19a6541a03b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-6451-560009364515630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-6451-56) 2015-02-170000-00-00NoNoCurrent
0093-6451-980009364519890 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-6451-98) 2015-02-170000-00-00NoNoCurrent