FDA.reportPublic FDA data

topcare esomeprazole magnesium

Product NDC
36800-627
11-digit product format
368000627
Labeler code
36800
Product ID
36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ce
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-03-12
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
topcare esomeprazole magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui606726

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
36800-627-01topcare esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
36800-627-01topcare esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
36800-627-03topcare esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35
36800-627-03topcare esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-627TOPCARE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 4 package rows20240905_86384845-0bea-490b-b04a-5770ef88b639.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN86384845-0bea-490b-b04a-5770ef88b6395
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD86384845-0bea-490b-b04a-5770ef88b6395
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY86384845-0bea-490b-b04a-5770ef88b6395
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY86384845-0bea-490b-b04a-5770ef88b6395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-627-01368000627011 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-03-120000-00-00NoNoCurrent
36800-627-03368000627033 BOTTLE in 1 CARTON (36800-627-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-03-120000-00-00NoNoCurrent