Atovaquone NDC 50268-119

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-119Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0119Add 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 NDC	11-digit (billing)	Package	Copy
50268-119-12	50268011912	20 CUP in 1 BOX (50268-119-12) / 5 mL in 1 CUP (50268-119-11)Marketed from Oct 14, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Atovaquone
Generic name (nonproprietary): atovaquone
Active ingredients: Atovaquone — 750 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202960
Marketing start: Oct 14, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 50268-119_4124a674-5e02-72c3-e063-6294a90ad785SPL ID 4124a674-5e02-72c3-e063-6294a90ad785SPL set ID 4124ad97-f6b9-8afb-e063-6294a90ab970RxCUI 308429UNII Y883P1Z2LT
Pharmacologic class: Antimalarial; Antiprotozoal

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

N450268011912 followed by a unit qualifier and the quantity

Package 50268-0119-12. 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

Current FDA label (SPL), effective Oct 14, 2025.

Indications (excerpt from the label)

Atovaquone oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2) Limitations of Use (1.3) : Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with atovaquone oral suspension has not been studied. The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pne…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202960

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

FDA NDC Directory listings under ANDA 202960
Product	Strength	Form · route	Labeler	Product NDC
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Amneal Pharmaceuticals LLC	65162-693
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	AvKARE	73190-098