ATOVAQUONE
- Product NDC
- 50268-119
- 11-digit product format
- 502680119
- Labeler code
- 50268
- Product ID
- 50268-119_4124a674-5e02-72c3-e063-6294a90ad785
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATOVAQUONE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA202960
- Marketing category
- ANDA
- Marketing start
- 2025-10-14
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ATOVAQUONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATOVAQUONE | 750 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y883P1Z2LT |
| Rxcui | 308429 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-119-11 | ATOVAQUONE | 5 mL in 1 CUP | SUSPENSION | 5 | | 1 |
| 50268-119-12 | ATOVAQUONE | 20 in 1 BOX | SUSPENSION | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-119-11 | 50268011911 | 5 mL in 1 CUP | 5 ml | | | | Historical |
| 50268-119-12 | 50268011912 | 20 CUP in 1 BOX (50268-119-12) / 5 mL in 1 CUP (50268-119-11) | 20 cup | 2025-10-14 | No | No | Historical |