FDA.reportPublic FDA data

TopCare Omeprazole delayed release

Product NDC
36800-121
11-digit product format
368000121
Labeler code
36800
Product ID
36800-121_f384bca8-e266-489a-8d87-3df17e7d0a56
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
NDA022032
Marketing category
NDA
Marketing start
2016-02-02
Substance
OMEPRAZOLE
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 Omeprazole delayed release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-121-01TopCare Omeprazole delayed release1 in 1 CARTONTABLET, DELAYED RELEASE16
36800-121-01TopCare Omeprazole delayed release14 in 1 BOTTLETABLET, DELAYED RELEASE146
36800-121-03TopCare Omeprazole delayed release3 in 1 CARTONTABLET, DELAYED RELEASE36
36800-121-03TopCare Omeprazole delayed release14 in 1 BOTTLETABLET, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-121TOPCARE OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 4 package rows20240901_8ed57521-e69a-4563-9ce2-4f6d667f065d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN8ed57521-e69a-4563-9ce2-4f6d667f065d6
402014omeprazole 20 MG Delayed Release Oral TabletSCD8ed57521-e69a-4563-9ce2-4f6d667f065d6
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY8ed57521-e69a-4563-9ce2-4f6d667f065d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-121-01368000121011 BOTTLE in 1 CARTON (36800-121-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2016-02-170000-00-00NoNoCurrent
36800-121-03368000121033 BOTTLE in 1 CARTON (36800-121-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2016-02-020000-00-00NoNoCurrent