NDC codes

FDA NDC Directory
Product NDC (as listed)65162-693Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0693Add 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 NDC11-digit (billing)PackageCopy
65162-693-8865162069388651620693881 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLEMarketed from Feb 9, 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
Generic name (nonproprietary)
atovaquone
Active ingredients
Atovaquone — 750 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202960
Marketing start
Listing expires
Identifiers
Product ID 65162-693_ea283214-c6a9-42be-a5fe-b35a74aa56afSPL ID ea283214-c6a9-42be-a5fe-b35a74aa56afSPL set ID b7398fcf-522a-488a-8dd6-051561f62804RxCUI 308429UNII Y883P1Z2LTUPC 0365162693881
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

N465162069388 followed by a unit qualifier and the quantity

Package 65162-0693-88. 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 .

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 jirovecii Pne…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-693

What is NDC 65162-693?
65162-693 is the product NDC for Atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, 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?
Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 202960

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

FDA NDC Directory listings under ANDA 202960
ProductStrengthForm · routeLabelerProduct NDC
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAvPAK50268-119
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAvKARE73190-098

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