Prescription drug · ANDA
atovaquone NDC 68462-421
Atovaquone 750 mg/5mL · Suspension · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-421-21 | 68462042121 | 210 mL in 1 BOTTLE (68462-421-21)Marketed from Dec 31, 2017 | |
| 68462-421-69 | 68462042169 | 42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCHMarketed from Dec 31, 2017 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209685
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-421_b221c446-0200-4c11-bd0c-ff9ec502bc19SPL ID b221c446-0200-4c11-bd0c-ff9ec502bc19SPL set ID 9045ba6f-938e-4717-bfa2-a3efe52f04cdRxCUI 308429UNII Y883P1Z2LTUPC 0368462421215
- 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
N468462042121followed by a unit qualifier and the quantityPackage 68462-0421-21. 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 o…
Excerpt only. Read the full label for complete information.