Atovaquone NDC 81033-104

NDC codes

FDA NDC Directory

Product NDC (as listed)81033-104Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81033-0104Add 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
81033-104-22	81033010422	20 CUP, UNIT-DOSE in 1 CARTON (81033-104-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)Marketed from Sep 15, 2025
81033-104-42	81033010442	42 CUP, UNIT-DOSE in 1 CARTON (81033-104-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)Marketed from Jun 17, 2024
81033-104-50	81033010450	50 CUP, UNIT-DOSE in 1 CARTON (81033-104-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)Marketed from Jun 17, 2024

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: Kesin Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212918
Marketing start: Jun 17, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 81033-104_3edaf9cd-76b2-a531-e063-6294a90a7e1aSPL ID 3edaf9cd-76b2-a531-e063-6294a90a7e1aSPL set ID 16b69156-e5de-c601-e063-6394a90afeaeRxCUI 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

N481033010422 followed by a unit qualifier and the quantity

Package 81033-0104-22. 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 Sep 15, 2025.

Indications (excerpt from the label)

1 INDICATIONS AND USAGE ------------------- INDICATIONS AND USAGE -------------------- 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 has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212918

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

FDA NDC Directory listings under ANDA 212918
Product	Strength	Form · route	Labeler	Product NDC
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	A2A Integrated Pharmaceuticals, LLC	73141-104
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Golden State Medical Supply, Inc.	51407-642
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Bionpharma Inc.	69452-252