Malarone NDC 0173-0675

NDC codes

FDA NDC Directory

Product NDC (as listed)0173-0675Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00173-0675Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0173-0675-01	00173067501	100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01)Marketed from Jul 26, 2000
0173-0675-02	00173067502	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 LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021078
Marketing start: Jul 26, 2000
Listing expires: Dec 31, 2027
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

N400173067501 followed by a unit qualifier and the quantity

Package 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 Jun 10, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021078

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021078
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
Malaroneatovaquone and proguanil hydrochloride	Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1	Tablet, Film coatedOral	GlaxoSmithKline LLC	0173-0676
Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Prasco Laboratories	66993-060