What is NDC 68462-421?

68462-421 is the product NDC for atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for atovaquone?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

atovaquone NDC 68462-421 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-421Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0421Add 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
68462-421-21	68462042121	210 mL in 1 BOTTLE (68462-421-21)Marketed from Dec 31, 2017
68462-421-69	68462042169	42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCHMarketed from Dec 31, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): atovaquone
Generic name (nonproprietary): atovaquone
Active ingredients: Atovaquone — 750 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209685
Marketing start: Dec 31, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 68462-421_b221c446-0200-4c11-bd0c-ff9ec502bc19SPL ID b221c446-0200-4c11-bd0c-ff9ec502bc19SPL set ID 9045ba6f-938e-4717-bfa2-a3efe52f04cdRxCUI 308429UNII Y883P1Z2LTUPC 0368462421215
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

N468462042121 followed by a unit qualifier and the quantity

Package 68462-0421-21. 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 May 6, 2026.

Indications (excerpt from the label)

Atovaquone 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 atovaquone has not been studied. • The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovecii Pneumonia Atovaquone o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-421

What is NDC 68462-421?: 68462-421 is the product NDC for atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: atovaquone.
What is the active ingredient?: Atovaquone.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for atovaquone?: 20 other product NDCs are listed under this name. See all atovaquone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other atovaquone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	AvKARE	73190-098	73190-0098-21
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	AvPAK	50268-119	50268-0119-12
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-0956	00121-0956-08
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	A2A Integrated Pharmaceuticals, LLC	73141-104	73141-0104-42
Atovaquoneatovaquone oral suspension	Atovaquone 750 mg/5mL	SuspensionOral	Major Pharmaceuticals	0904-7459	00904-7459-2500904-7459-53
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Kesin Pharma	81033-104	81033-0104-2281033-0104-4281033-0104-50
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	NorthStar RxLLC	72603-248	72603-0248-01
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-1016	00121-1016-1800121-1016-42
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Abon Pharmaceuticals, LLC	42239-001	42239-0001-0842239-0001-66
Atovaquone	Atovaquone 750 mg/5mL	SuspensionOral	Bionpharma Inc.	69452-252	69452-0252-87

All 21 atovaquone NDCs