Atovaquone and Proguanil Hydrochloride NDC 71335-3160

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-3160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-3160Add 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
71335-3160-1	71335316001	10 TABLET, FILM COATED in 1 BOTTLE (71335-3160-1)Marketed from Jul 27, 2026
71335-3160-2	71335316002	24 TABLET, FILM COATED in 1 BOTTLE (71335-3160-2)Marketed from Jul 27, 2026
71335-3160-3	71335316003	5 TABLET, FILM COATED in 1 BOTTLE (71335-3160-3)Marketed from Jul 27, 2026
71335-3160-4	71335316004	12 TABLET, FILM COATED in 1 BOTTLE (71335-3160-4)Marketed from Jul 27, 2026
71335-3160-5	71335316005	100 TABLET, FILM COATED in 1 BOTTLE (71335-3160-5)Marketed from Jul 27, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and Proguanil Hydrochloride
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: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091211
Marketing start: Sep 15, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71335-3160_fc935266-98cd-4a37-9b59-bdc6f0910b80SPL ID fc935266-98cd-4a37-9b59-bdc6f0910b80SPL set ID e4ff57f7-07af-4872-ac3a-c521e098ccfeRxCUI 864675UNII Y883P1Z2LT, R71Y86M0WT
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

N471335316001 followed by a unit qualifier and the quantity

Package 71335-3160-01. 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 Jul 27, 2026.

Indications (excerpt from the label)

Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium 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 Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091211

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

FDA NDC Directory listings under ANDA 091211
Product	Strength	Form · route	Labeler	Product NDC
Atovaquone and Proguanil Hydrochloride Pediatric	Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc.,USA	68462-402
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc.,USA	68462-404
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-245
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-879