Atovaquone Oral Suspension
- Product NDC
- 81033-105
- 11-digit product format
- 810330105
- Labeler code
- 81033
- Product ID
- 81033-105_4a2e2cbc-ee5c-94ed-e063-6294a90aef55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Kesin Pharma Corporation
- Application
- ANDA210510
- Marketing category
- ANDA
- Marketing start
- 2026-02-06
- Substance
- ATOVAQUONE
- Active strength
- 750 mg/5mL
- Pharmacologic classes
- Antimalarial [EPC], Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atovaquone Oral Suspension
- Listing expiration
- 2027-12-31
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 |
|---|
| 81033-105-05 | Atovaquone Oral Suspension | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 1 |
| 81033-105-22 | Atovaquone Oral Suspension | 20 in 1 CARTON | SUSPENSION | 20 | | 1 |
| 81033-105-42 | Atovaquone Oral Suspension | 42 in 1 CARTON | SUSPENSION | 42 | | 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 |
|---|
| 81033-105-05 | 81033010505 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 81033-105-22 | 81033010522 | 20 CUP, UNIT-DOSE in 1 CARTON (81033-105-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-105-05) | | 2026-02-06 | No | No | Current |
| 81033-105-42 | 81033010542 | 42 CUP, UNIT-DOSE in 1 CARTON (81033-105-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-105-05) | | 2026-02-06 | No | No | Current |