Prescription drug · NDA
Malarone (Atovaquone and proguanil hydrochloride) NDC 0173-0675
Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0675-01 | 0017306750100173067501 | 100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01)Marketed from Jul 26, 2000 | |
| 0173-0675-02 | 0017306750200173067502 | 24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02)Marketed from Jul 26, 2000 |
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)
- Malarone
- Generic name (nonproprietary)
- atovaquone and proguanil hydrochloride
- Active ingredients
- Atovaquone — 250 mg/1Proguanil hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021078
- Marketing start
- Listing expires
- Other FDA classes
- Dihydrofolate Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0173-0675_7afd7871-8367-49db-9ba1-f33b3fc0f857SPL ID 7afd7871-8367-49db-9ba1-f33b3fc0f857SPL set ID fc22e8d8-3bfb-4f70-a599-dd81262a4887RxCUI 864675, 864679, 864681, 864685UNII Y883P1Z2LT, R71Y86M0WTUPC 0301730676016, 0301730675019
- 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
N400173067501followed by a unit qualifier and the quantityPackage 00173-0675-01. 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)
MALARONE is an antimalarial indicated for: • prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria. MALARONE has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure ra…
Excerpt only. Read the full label for complete information.
About NDC 0173-0675
- What is NDC 0173-0675?
- 0173-0675 is the product NDC for Malarone, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Malarone (Atovaquone and proguanil hydrochloride).
- What is the active ingredient?
- Atovaquone, Proguanil hydrochloride.
- 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 Malarone?
- 1 other product NDC are listed under this name. See all Malarone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Malarone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Malaroneatovaquone and proguanil hydrochloride | Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0676 | 00173-0676-01 |
Other NDCs under NDA 021078
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 and Proguanil HClatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2980 |
| Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-060 |
| Malaroneatovaquone and proguanil hydrochloride | Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0676 |