Prescription drug · NDA
Mepron (atovaquone) NDC 0173-0547
Atovaquone 750 mg/5mL · Suspension · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0547-00 | 00173054700 | 42 POUCH in 1 DOSE PACK (0173-0547-00) / 5 mL in 1 POUCHMarketed from Sep 18, 1998 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Mepron
- Generic name (nonproprietary)
- atovaquone
- Active ingredients
- Atovaquone — 750 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- GlaxoSmithKline LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020500
- Marketing start
- Listing expires
- Identifiers
- Product ID 0173-0547_005bf875-7785-4b73-8c03-fa75737de8a9SPL ID 005bf875-7785-4b73-8c03-fa75737de8a9SPL set ID b426b6bf-f07e-4580-97ae-dfca1ddf5b8fRxCUI 211947, 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
N400173054700followed by a unit qualifier and the quantityPackage 00173-0547-00. 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)
MEPRON 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 MEPRON has not been studied. • The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneumonia MEPRON oral suspension …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020500
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 |
|---|---|---|---|---|
| Mepronatovaquone | Atovaquone 750 mg/5mL | SuspensionOral | GlaxoSmithKline LLC | 0173-0665 |