FDA.reportPublic FDA data

Topcare Esomeprazole Magnesium

Product NDC
36800-636
11-digit product format
368000636
Labeler code
36800
Product ID
36800-636_429dfe02-50b7-414a-98af-cc3c9b0afddb
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-22
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-636-01Topcare Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE16
36800-636-01Topcare Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
36800-636-02Topcare Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE26
36800-636-02Topcare Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
36800-636-03Topcare Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
36800-636-03Topcare Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-636TOPCARE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC]6Legacy NDC, 6 package rows20240901_32918b45-ff9a-45bd-8d90-e008bf4d8458.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN32918b45-ff9a-45bd-8d90-e008bf4d84586
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD32918b45-ff9a-45bd-8d90-e008bf4d84586
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY32918b45-ff9a-45bd-8d90-e008bf4d84586
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY32918b45-ff9a-45bd-8d90-e008bf4d84586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-636-01368000636011 BOTTLE in 1 CARTON (36800-636-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-220000-00-00NoNoCurrent
36800-636-02368000636022 BOTTLE in 1 CARTON (36800-636-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-09-220000-00-00NoNoCurrent
36800-636-03368000636033 BOTTLE in 1 CARTON (36800-636-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-220000-00-00NoNoCurrent