Prescription drug · ANDA
Atovaquone Oral Suspension (Atovaquone) NDC 81033-105
Atovaquone 750 mg/5mL · Suspension · Oral · Kesin Pharma Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-105-22 | 81033010522 | 20 CUP, UNIT-DOSE in 1 CARTON (81033-105-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-105-05)Marketed from Feb 6, 2026 | |
| 81033-105-42 | 81033010542 | 42 CUP, UNIT-DOSE in 1 CARTON (81033-105-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-105-05)Marketed from Feb 6, 2026 |
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 Oral Suspension
- Generic name (nonproprietary)
- atovaquone
- Active ingredients
- Atovaquone — 750 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Kesin Pharma CorporationNDC labeler code 81033
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210510
- Marketing start
- Listing expires
- Identifiers
- Product ID 81033-105_4a2e2cbc-ee5c-94ed-e063-6294a90aef55SPL ID 4a2e2cbc-ee5c-94ed-e063-6294a90aef55SPL set ID 4a2e2c4b-85aa-9b30-e063-6294a90a7bd9RxCUI 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
N481033010522followed by a unit qualifier and the quantityPackage 81033-0105-22. 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 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 jirovecii Pneu…
Excerpt only. Read the full label for complete information.
About NDC 81033-105
- What is NDC 81033-105?
- 81033-105 is the product NDC for Atovaquone Oral Suspension (atovaquone), Atovaquone 750 mg/5mL suspension, listed with the FDA by Kesin Pharma Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atovaquone Oral Suspension (Atovaquone).
- What is the active ingredient?
- Atovaquone.
- Who is the labeler?
- Kesin Pharma Corporation, NDC labeler code 81033. 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 Oral Suspension?
- 1 other product NDC are listed under this name. See all Atovaquone Oral Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atovaquone Oral Suspension 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 Oral Suspensionatovaquone | Atovaquone 750 mg/5mL | SuspensionOral | KVK-Tech, Inc. | 10702-223 | 10702-0223-21 |
Other NDCs under ANDA 210510
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 Oral Suspensionatovaquone | Atovaquone 750 mg/5mL | SuspensionOral | KVK-Tech, Inc. | 10702-223 |