Prescription drug · ANDA

Atovaquone NDC 0121-1016

Atovaquone 750 mg/5mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma

NDC codes

FDA NDC Directory
Product NDC (as listed)0121-1016Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-1016Add 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
0121-1016-18001211016183 TRAY in 1 CASE (0121-1016-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05)Marketed from Jan 10, 2024
0121-1016-42001211016427 TRAY in 1 CASE (0121-1016-42) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05)Marketed from Jan 10, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214272
Marketing start
Listing expires
Identifiers
Product ID 0121-1016_0145c97d-2d5e-4fcd-ae76-85e4ae946350SPL ID 0145c97d-2d5e-4fcd-ae76-85e4ae946350SPL set ID df6086d3-6100-422a-bf23-e9610027749bRxCUI 308429UNII Y883P1Z2LT
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

N400121101618 followed by a unit qualifier and the quantity

Package 00121-1016-18. 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 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 oral su…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-1016

What is NDC 0121-1016?
0121-1016 is the product NDC for Atovaquone, Atovaquone 750 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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
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 750 mg/5mLSuspensionOralA2A Integrated Pharmaceuticals, LLC73141-10473141-0104-42
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/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 21 Atovaquone NDCs

Other NDCs under ANDA 214272

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

FDA NDC Directory listings under ANDA 214272
ProductStrengthForm · routeLabelerProduct NDC
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0956
AtovaquoneAtovaquone 750 mg/5mLSuspensionOralAbon Pharmaceuticals, LLC42239-001
Atovaquoneatovaquone oral suspensionAtovaquone 750 mg/5mLSuspensionOralMajor Pharmaceuticals0904-7459

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