NDC codes

FDA NDC Directory
Product NDC (as listed)57841-1150Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57841-1150Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
57841-1150-2578411150022 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)Marketed from Mar 9, 2020
57841-1150-4578411150042 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)Marketed from Sep 24, 2021 · Sample package

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Talicia
Generic name (nonproprietary)
omeprazole magnesium, amoxicillin and rifabutin
Active ingredients
Omeprazole magnesium — 10 mg/1Amoxicillin — 250 mg/1Rifabutin — 12.5 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213004
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Penicillins (Chemical structure)Proton Pump Inhibitors (Mechanism)Rifamycins (Chemical structure)
Identifiers
Product ID 57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98SPL ID 0649301c-fc4e-42a4-a62d-9a023a3f9f98SPL set ID 68c4e9dc-dbcf-4151-b6f7-5e4b9922b76fRxCUI 2262026, 2262032UNII 426QFE7XLK, 804826J2HU, 1W306TDA6SUPC 0357841115012
Pharmacologic class
Penicillin-class Antibacterial; Proton Pump Inhibitor; Rifamycin Antimycobacterial

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

N457841115002 followed by a unit qualifier and the quantity

Package 57841-1150-02. 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

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