berkley and jensen omeprazole (omeprazole) NDC 68391-103

Product information

Brand name (proprietary)

berkley and jensen omeprazole

Generic name (nonproprietary)

omeprazole

Active ingredients

Omeprazole — 20 mg/1

Dosage form

Tablet, Orally disintegrating, Delayed release

Route

Oral

Labeler

BJWC

Product type

Over-the-counter drug

Marketing category

NDA — New Drug ApplicationApplication NDA 209400

Marketing start

Mar 9, 2020

Listing expires

Dec 31, 2027

Other FDA classes

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

Identifiers

Product ID 68391-103_64916be2-9c0a-4eeb-8d44-7e16b1faa8e9SPL ID 64916be2-9c0a-4eeb-8d44-7e16b1faa8e9

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

N468391010355 followed by a unit qualifier and the quantity Copy

Package 68391-0103-55. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 209400

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