Atovaquone and Proguanil HCl NDC 50090-2980

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-2980Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-2980Add 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
50090-2980-0	50090298000	7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0)Marketed from May 4, 2017
50090-2980-1	50090298001	12 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1)Marketed from Apr 27, 2017
50090-2980-2	50090298002	14 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2)Marketed from May 8, 2017
50090-2980-3	50090298003	16 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3)Marketed from Apr 28, 2017
50090-2980-4	50090298004	24 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4)Marketed from Apr 21, 2017
50090-2980-5	50090298005	5 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5)Marketed from Apr 25, 2017
50090-2980-6	50090298006	10 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6)Marketed from Nov 16, 2017
50090-2980-7	50090298007	100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7)Marketed from Jan 17, 2018
50090-2980-8	50090298008	20 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8)Marketed from Feb 1, 2018
50090-2980-9	50090298009	30 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9)Marketed from Feb 12, 2018

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 HCl
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: A-S Medication Solutions
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021078
Marketing start: Jul 27, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers: Product ID 50090-2980_db61f577-1818-4643-8712-23db5c162ae6SPL ID db61f577-1818-4643-8712-23db5c162ae6SPL set ID 593baf3d-bd9e-4a44-8f90-125aa4a7a99eRxCUI 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

N450090298000 followed by a unit qualifier and the quantity

Package 50090-2980-00. 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 Oct 23, 2023.

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 have been shown to be effectiv…

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
Malaroneatovaquone and proguanil hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	GlaxoSmithKline LLC	0173-0675
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