Prescription drug · ANDA
Atovaquone NDC 68999-528
Atovaquone 750 mg/5mL · Suspension · Oral · Chartwell Governmental & Specialty RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-528-24 | 68999052824 | 2 TRAY in 1 BOX (68999-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-528-45)Marketed from Oct 25, 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
- Chartwell Governmental & Specialty RX, LLC.NDC labeler code 68999
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207833
- Marketing start
- Listing expires
- Identifiers
- Product ID 68999-528_430808cb-6a2f-94ee-e063-6394a90ab6fdSPL ID 430808cb-6a2f-94ee-e063-6394a90ab6fdSPL set ID e6770b85-54f8-4969-af02-7d81586be761RxCUI 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
N468999052824followed by a unit qualifier and the quantityPackage 68999-0528-24. 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 trimethoprimsulfamethoxazole (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 [(Aa) 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 TMPSMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii…
Excerpt only. Read the full label for complete information.
About NDC 68999-528
- What is NDC 68999-528?
- 68999-528 is the product NDC for Atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Chartwell Governmental & Specialty RX, LLC.. It has 1 package NDC, 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?
- Chartwell Governmental & Specialty RX, LLC., NDC labeler code 68999. 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 | Abon Pharmaceuticals, LLC | 42239-001 | 42239-0001-0842239-0001-66 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Bionpharma Inc. | 69452-252 | 69452-0252-87 |
Other NDCs under ANDA 207833
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 | Chartwell RX, LLC | 62135-528 |