Atovaquone
- Product NDC
- 17856-0631
- 11-digit product format
- 178560631
- Labeler code
- 17856
- Product ID
- 17856-0631_34f352d5-bdca-df12-e063-6294a90a54bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA210692
- Marketing category
- ANDA
- Marketing start
- 2018-10-11
- Substance
- ATOVAQUONE
- Active strength
- 750 mg/5mL
- Pharmacologic classes
- Antimalarial [EPC], Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Y883P1Z2LT | ATOVAQUONE | 95233-18-4 | ATOVAQUONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-0631-1 | 17856063101 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0631-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0631-2) | 2024-09-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Atovaquone | ATLANTIC BIOLOGICALS CORP. | 2025-05-12 | HUMAN PRESCRIPTION DRUG LABEL | 2 |