NDC codes

FDA NDC Directory
Product NDC (as listed)70166-488Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70166-0488Add the package segment from the table below.

Product information

Brand name (proprietary)
Atovaquone
Generic name (nonproprietary)
atovaquone
Active ingredients
Atovaquone — 750 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
LohxaNDC labeler code 70166
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210692
Marketing start
Listing expires
Identifiers
Product ID 70166-488_30ca1c6b-6bc5-3dba-e063-6394a90a5656SPL ID 30ca1c6b-6bc5-3dba-e063-6394a90a5656SPL set ID ba3cad0d-cce9-424f-ba5c-557dba8bef12RxCUI 308429UNII Y883P1Z2LTUPC 0370166488050
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.

Product label

Current FDA label (SPL), effective .

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 oral suspension has not been studied. • The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied. 1.1 Prevention of Pneumocystis jirovec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70166-488

What is NDC 70166-488?
70166-488 is the product NDC for Atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Lohxa.
What drug is associated with this NDC?
Atovaquone.
What is the active ingredient?
Atovaquone.
Who is the labeler?
Lohxa, NDC labeler code 70166. 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?
19 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAvKARE73190-09873190-0098-21
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAvPAK50268-11950268-0119-12
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-095600121-0956-08
Atovaquoneatovaquone oral suspensionAtovaquone 750 mg/5mLSuspensionOralMajor Pharmaceuticals0904-745900904-7459-2500904-7459-53
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralKesin Pharma81033-10481033-0104-2281033-0104-4281033-0104-50
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralNorthStar RxLLC72603-24872603-0248-01
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-101600121-1016-1800121-1016-42
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAbon Pharmaceuticals, LLC42239-00142239-0001-0842239-0001-66
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralBionpharma Inc.69452-25269452-0252-87
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralLupin Pharmaceuticals, Inc.70748-29970748-0299-01

All 20 Atovaquone NDCs

Other NDCs under ANDA 210692

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

FDA NDC Directory listings under ANDA 210692
ProductStrengthForm · routeLabelerProduct NDC
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-0631
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-8631
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralCamber Pharmaceuticals, Inc.31722-629
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAmerican Health Packaging60687-534
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralLupin Pharmaceuticals, Inc.70748-299
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralNorthStar RxLLC72603-248

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in