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NDC 00121-1016-42 Atovaquone 750 mg/5mL Details

Atovaquone 750 mg/5mL

Atovaquone is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is ATOVAQUONE.

MedlinePlus Drug Summary

Atovaquone is used to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia (PCP; type of pneumonia most likely to affect people with human immunodeficiency virus [HIV]) in teenagers and adults. Atovaquone is also used to prevent PCP in teenagers and adults who cannot take another medication used for prevention. Atovaquone is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain types of protozoa that can cause pneumonia.

Related Packages: 00121-1016-42
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Atovaquone

Product Information

NDC	00121-1016
Product ID	0121-1016_053210ad-3cd0-406a-bd66-05d866924ae7
Associated GPIs
GCN Sequence Number	023399
GCN Sequence Number Description	atovaquone ORAL SUSP 750 MG/5ML ORAL
HIC3	W4K
HIC3 Description	ANTIPROTOZOAL DRUGS,MISCELLANEOUS
GCN	34490
HICL Sequence Number	006619
HICL Sequence Number Description	ATOVAQUONE
Brand/Generic	Generic
Proprietary Name	Atovaquone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Atovaquone
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	750
Active Ingredient Units	mg/5mL
Substance Name	ATOVAQUONE
Labeler Name	PAI Holdings, LLC
Pharmaceutical Class	Antimalarial [EPC], Antiprotozoal [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA214272
Listing Certified Through	2025-12-31

Package

NDC 00121-1016-42 (00121101642)

Pricing Information	N/A
NDC Package Code	0121-1016-42
Billing NDC	00121101642
Package	7 TRAY in 1 CASE (0121-1016-42) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05)
Marketing Start Date	2024-01-10
NDC Exclude Flag	N