Atovaquone
- Product NDC
- 81033-104
- 11-digit product format
- 810330104
- Labeler code
- 81033
- Product ID
- 81033-104_3edaf9cd-76b2-a531-e063-6294a90a7e1a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Kesin Pharma
- Application
- ANDA212918
- Marketing category
- ANDA
- Marketing start
- 2024-06-17
- 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 |
|---|
| 81033-104-05 | Atovaquone | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 5 |
| 81033-104-22 | Atovaquone | 20 in 1 CARTON | SUSPENSION | 20 | | 5 |
| 81033-104-42 | Atovaquone | 42 in 1 CARTON | SUSPENSION | 42 | | 5 |
| 81033-104-50 | Atovaquone | 50 in 1 CARTON | SUSPENSION | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81033-104 | ATOVAQUONE SUSPENSION [KESIN PHARMA] | 4 | Current NDC, 4 package rows | 20241207_16b69156-e5de-c601-e063-6394a90afeae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81033-104-05 | 81033010405 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 81033-104-22 | 81033010422 | 20 CUP, UNIT-DOSE in 1 CARTON (81033-104-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) | | 2025-09-15 | No | No | Historical |
| 81033-104-42 | 81033010442 | 42 CUP, UNIT-DOSE in 1 CARTON (81033-104-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) | | 2024-06-17 | No | No | Historical |
| 81033-104-50 | 81033010450 | 50 CUP, UNIT-DOSE in 1 CARTON (81033-104-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) | | 2024-06-17 | No | No | Historical |