topcare omeprazole (omeprazole) NDC 36800-601

Product information

Brand name (proprietary)

topcare omeprazole

Generic name (nonproprietary)

omeprazole

Active ingredients

Omeprazole — 20 mg/1

Dosage form

Tablet, Orally disintegrating, Delayed release

Route

Oral

Labeler

Topco Associates LLC

Product type

Over-the-counter drug

Marketing category

NDA — New Drug ApplicationApplication NDA 209400

Marketing start

Apr 2, 2018

Listing expires

Dec 31, 2026

Other FDA classes

Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)

Identifiers

Product ID 36800-601_0edd49e4-cf9e-42db-8bbb-78ce370ac480SPL ID 0edd49e4-cf9e-42db-8bbb-78ce370ac480SPL set ID 436c5ea1-c5ee-481f-803d-439f65873b1cRxCUI 2003656UNII KG60484QX9

Pharmacologic class

Proton Pump Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N436800060155 followed by a unit qualifier and the quantity Copy

Package 36800-0601-55. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Other NDCs under NDA 209400

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.