Prescription drug · ANDA
Atovaquone NDC 69452-252
Atovaquone 750 mg/5mL · Suspension · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-252-87 | 69452025287 | 1 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
- Labeler
- Bionpharma Inc.
- 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
N469452025287followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 212918
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Kesin Pharma | 81033-104 |