Prescription drug · NDA
Mepron (Atovaquone) NDC 0173-0665
Atovaquone 750 mg/5mL · Suspension · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0665-18 | 00173066518 | 210 mL in 1 BOTTLE (0173-0665-18)Marketed from Feb 28, 1995 |
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 LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020500
- Marketing start
- Listing expires
- Identifiers
- Product ID 0173-0665_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
N400173066518followed by a unit qualifier and the quantityPackage 00173-0665-18. 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.
About NDC 0173-0665
- What is NDC 0173-0665?
- 0173-0665 is the product NDC for Mepron (atovaquone), Atovaquone 750 mg/5mL suspension, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mepron (Atovaquone).
- What is the active ingredient?
- Atovaquone.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mepron?
- 1 other product NDC are listed under this name. See all Mepron NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mepron products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mepronatovaquone | Atovaquone 750 mg/5mL | SuspensionOral | GlaxoSmithKline LLC | 0173-0547 | 00173-0547-00 |
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 | 0173-0547 |