Prescription drug · ANDA
Atovaquone NDC 62135-528
Atovaquone 750 mg/5mL · Suspension · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-528-09 | 62135052809 | 210 mL in 1 BOTTLE (62135-528-09)Marketed from Jul 18, 2023 | |
| 62135-528-24 | 62135052824 | 2 TRAY in 1 BOX (62135-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45)Marketed from May 23, 2024 |
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 RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207833
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-528_19392345-2a5f-cbf6-e063-6394a90a61f1SPL ID 19392345-2a5f-cbf6-e063-6394a90a61f1SPL set ID de0e29b5-a4c7-405c-a5b9-438729d9ba3aRxCUI 308429UNII Y883P1Z2LTUPC 0362135528096
- 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
N462135052809followed by a unit qualifier and the quantityPackage 62135-0528-09. 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.