Prescription drug · ANDA
Atovaquone NDC 42239-001
Atovaquone 750 mg/5mL · Suspension · Oral · Abon Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42239-001-08 | 42239000108 | 1 BOTTLE in 1 CARTON (42239-001-08) / 210 mL in 1 BOTTLEMarketed from Nov 14, 2023 | |
| 42239-001-66 | 42239000166 | 6 CUP, UNIT-DOSE in 1 TRAY (42239-001-66) / 5 mL in 1 CUP, UNIT-DOSE (42239-001-17)Marketed from May 1, 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
- Abon Pharmaceuticals, LLCNDC labeler code 42239
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214272
- Marketing start
- Listing expires
- Identifiers
- Product ID 42239-001_34f67d35-7080-d493-e063-6294a90a5cc9SPL ID 34f67d35-7080-d493-e063-6294a90a5cc9SPL set ID 2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd08RxCUI 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
N442239000108followed by a unit qualifier and the quantityPackage 42239-0001-08. 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 sus…
Excerpt only. Read the full label for complete information.
About NDC 42239-001
- What is NDC 42239-001?
- 42239-001 is the product NDC for Atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Abon Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atovaquone.
- What is the active ingredient?
- Atovaquone.
- Who is the labeler?
- Abon Pharmaceuticals, LLC, NDC labeler code 42239. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atovaquone?
- 20 other product NDCs are listed under this name. See all Atovaquone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atovaquone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | AvKARE | 73190-098 | 73190-0098-21 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | AvPAK | 50268-119 | 50268-0119-12 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0956 | 00121-0956-08 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | A2A Integrated Pharmaceuticals, LLC | 73141-104 | 73141-0104-42 |
| Atovaquoneatovaquone oral suspension | Atovaquone 750 mg/5mL | SuspensionOral | Major Pharmaceuticals | 0904-7459 | 00904-7459-2500904-7459-53 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Kesin Pharma | 81033-104 | 81033-0104-2281033-0104-4281033-0104-50 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | NorthStar RxLLC | 72603-248 | 72603-0248-01 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1016 | 00121-1016-1800121-1016-42 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Lupin Pharmaceuticals, Inc. | 70748-299 | 70748-0299-01 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Bionpharma Inc. | 69452-252 | 69452-0252-87 |
Other NDCs under ANDA 214272
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 | PAI Holdings, LLC dba PAI Pharma | 0121-0956 |
| Atovaquoneatovaquone oral suspension | Atovaquone 750 mg/5mL | SuspensionOral | Major Pharmaceuticals | 0904-7459 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1016 |