Atovaquone
- Product NDC
- 68999-528
- 11-digit product format
- 689990528
- Labeler code
- 68999
- Product ID
- 68999-528_430808cb-6a2f-94ee-e063-6394a90ab6fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC.
- Application
- ANDA207833
- Marketing category
- ANDA
- Marketing start
- 2017-04-28
- 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 |
|---|
| 68999-528-24 | Atovaquone | 10 in 1 TRAY | SUSPENSION | 10 | | 1 |
| 68999-528-24 | Atovaquone | 2 in 1 BOX | SUSPENSION | 2 | | 1 |
| 68999-528-45 | Atovaquone | 5 mL in 1 CUP | SUSPENSION | 5 | | 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 |
|---|
| 68999-528-24 | 68999052824 | 2 TRAY in 1 BOX (68999-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-528-45) | 2 tray | 2025-10-25 | No | No | Historical |
| 68999-528-45 | 68999052845 | 5 mL in 1 CUP | 5 ml | | | | Historical |