What is NDC 68462-404?

68462-404 is the product NDC for Atovaquone and Proguanil Hydrochloride, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc.,USA. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Atovaquone, Proguanil hydrochloride.

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 and Proguanil Hydrochloride?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atovaquone and Proguanil Hydrochloride NDC 68462-404

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-404Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0404Add 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
68462-404-01	6846204040168462040401	100 TABLET, FILM COATED in 1 BOTTLE (68462-404-01)Marketed from Sep 15, 2011
68462-404-67	6846204046768462040467	2 BLISTER PACK in 1 CARTON (68462-404-67) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68462-404-44)Marketed from Sep 15, 2011

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 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: Glenmark Pharmaceuticals Inc.,USANDC labeler code 68462
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 68462-404_a6232b89-d1c0-4114-879d-6c9320a92eb2SPL ID a6232b89-d1c0-4114-879d-6c9320a92eb2SPL set ID 4b80d087-eaa7-448f-967e-344de7f16436RxCUI 864675, 864681UNII Y883P1Z2LT, R71Y86M0WTUPC 0368462402016, 0368462404010
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

N468462040401 followed by a unit qualifier and the quantity

Package 68462-0404-01. 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 Apr 24, 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)

About NDC 68462-404

What is NDC 68462-404?: 68462-404 is the product NDC for Atovaquone and Proguanil Hydrochloride, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, 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 and Proguanil Hydrochloride.
What is the active ingredient?: Atovaquone, Proguanil hydrochloride.
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 and Proguanil Hydrochloride?: 7 other product NDCs are listed under this name. See all Atovaquone and Proguanil Hydrochloride 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 and Proguanil Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atovaquone and Proguanil Hydrochloride	Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4160	00378-4160-01
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4162	00378-4162-01
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-869	51407-0869-0151407-0869-24
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-245	68001-0245-0068001-0245-15
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1302	50090-1302-0050090-1302-0150090-1302-02+6 more
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3160	71335-3160-0171335-3160-0271335-3160-03+2 more
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-879	63187-0879-1663187-0879-24

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	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1302
Atovaquone and Proguanil Hydrochloride	Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-879
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	Bryant Ranch Prepack	71335-3160
Atovaquone and Proguanil Hydrochloride Pediatric	Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc.,USA	68462-402