NDC codes

FDA NDC Directory
Product NDC (as listed)69452-252Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0252Add 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
69452-252-87694520252871 BOTTLE in 1 CARTON (69452-252-87) / 210 mL in 1 BOTTLEMarketed from Jun 1, 2021

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212918
Marketing start
Listing expires
Identifiers
Product ID 69452-252_4523911f-9d9c-4b0c-e063-6394a90ac76dSPL ID 4523911f-9d9c-4b0c-e063-6394a90ac76dSPL set ID bff4f4fc-6307-f414-e053-2a95a90ac0deRxCUI 308429UNII Y883P1Z2LTUPC 0369452252871
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

N469452025287 followed by a unit qualifier and the quantity

Package 69452-0252-87. 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 .

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 has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneumonia Atovaquone oral suspens…

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
ProductStrengthForm · routeLabelerProduct NDC
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralA2A Integrated Pharmaceuticals, LLC73141-104
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralGolden State Medical Supply, Inc.51407-642
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralKesin Pharma81033-104

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