FDA.reportPublic FDA data

topcare omeprazole

Product NDC
36800-601
11-digit product format
368000601
Labeler code
36800
Product ID
36800-601_0edd49e4-cf9e-42db-8bbb-78ce370ac480
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
NDA209400
Marketing category
NDA
Marketing start
2018-04-02
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui2003656

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-601-55topcare omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D35
36800-601-55topcare omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145
36800-601-74topcare omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D15
36800-601-74topcare omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-601-55EA - Each36800-6019bd49514-f86c-4532-a343-c4571a1c90dc12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-601TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 4 package rows20250205_436c5ea1-c5ee-481f-803d-439f65873b1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN436c5ea1-c5ee-481f-803d-439f65873b1c5
2003656omeprazole 20 MG Disintegrating Oral TabletSCD436c5ea1-c5ee-481f-803d-439f65873b1c5
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY436c5ea1-c5ee-481f-803d-439f65873b1c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-601-55368000601553 CARTON in 1 CARTON (36800-601-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-04-020000-00-00NoNoCurrent
36800-601-743680006017414 BLISTER PACK in 1 CARTON (36800-601-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-04-020000-00-00NoNoCurrent