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NDC 00121-0898-18 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: 00121-0898-18
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Atovaquone

Product Information

NDC	00121-0898
Product ID	0121-0898_9e2c72f3-ce14-4bcf-9fa6-b9533894d4dc
Associated GPIs	16400020001820
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	ANDA210692
Listing Certified Through	2024-12-31

Package

NDC 00121-0898-18 (00121089818)

Pricing Information	N/A
NDC Package Code	0121-0898-18
Billing NDC	00121089818
Package	3 TRAY in 1 CASE (0121-0898-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05)
Marketing Start Date	2021-02-05
NDC Exclude Flag	N