Atovaquone NDC 17856-0631

NDC codes

FDA NDC Directory

Product NDC (as listed)17856-0631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width17856-0631Add 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
17856-0631-1	17856063101	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0631-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0631-2)Marketed from Sep 4, 2024

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): Atovaquone
Generic name (nonproprietary): atovaquone
Active ingredients: Atovaquone — 750 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: ATLANTIC BIOLOGICALS CORP.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210692
Marketing start: Oct 11, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 17856-0631_34f352d5-bdca-df12-e063-6294a90a54bdSPL ID 34f352d5-bdca-df12-e063-6294a90a54bdSPL set ID f99a8a0c-2b42-4da0-8f5a-e963fc619e8bRxCUI 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

N417856063101 followed by a unit qualifier and the quantity

Package 17856-0631-01. 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 May 12, 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 jirov…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210692

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

FDA NDC Directory listings under ANDA 210692
Product	Strength	Form · route	Labeler	Product NDC
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Lupin Pharmaceuticals, Inc.	70748-299
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	NorthStar RxLLC	72603-248
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	American Health Packaging	60687-534
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-8631
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Lohxa	70166-488
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Camber Pharmaceuticals, Inc.	31722-629