Prescription drug · ANDA
Atovaquone NDC 70166-488
Atovaquone 750 mg/5mL · Suspension · Oral · Lohxa
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Atovaquone
- Generic name (nonproprietary)
- atovaquone
- Active ingredients
- Atovaquone — 750 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- LohxaNDC labeler code 70166
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210692
- Marketing start
- Listing expires
- Identifiers
- Product ID 70166-488_30ca1c6b-6bc5-3dba-e063-6394a90a5656SPL ID 30ca1c6b-6bc5-3dba-e063-6394a90a5656SPL set ID ba3cad0d-cce9-424f-ba5c-557dba8bef12RxCUI 308429UNII Y883P1Z2LTUPC 0370166488050
- 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.
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 jirovec…
Excerpt only. Read the full label for complete information.
About NDC 70166-488
- What is NDC 70166-488?
- 70166-488 is the product NDC for Atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Lohxa.
- What drug is associated with this NDC?
- Atovaquone.
- What is the active ingredient?
- Atovaquone.
- Who is the labeler?
- Lohxa, NDC labeler code 70166. 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?
- 19 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 |
| 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 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Lupin Pharmaceuticals, Inc. | 70748-299 | 70748-0299-01 |
Other NDCs under ANDA 210692
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 | ATLANTIC BIOLOGICALS CORP. | 17856-0631 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-8631 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Camber Pharmaceuticals, Inc. | 31722-629 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | American Health Packaging | 60687-534 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | Lupin Pharmaceuticals, Inc. | 70748-299 |
| Atovaquone | Atovaquone 750 mg/5mL | SuspensionOral | NorthStar RxLLC | 72603-248 |