ATOVAQUONE
- Product NDC
- 0904-7459
- 11-digit product format
- 009047459
- Labeler code
- 0904
- Product ID
- 0904-7459_9c1dfc30-52ac-4fec-a728-135917f39c1a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone Oral Suspension
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA214272
- Marketing category
- ANDA
- Marketing start
- 2024-07-08
- 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 |
|---|
| 0904-7459-25 | ATOVAQUONE | 3 in 1 CASE | SUSPENSION | 3 | | 6 |
| 0904-7459-25 | ATOVAQUONE | 6 in 1 TRAY | SUSPENSION | 6 | | 6 |
| 0904-7459-41 | ATOVAQUONE | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 6 |
| 0904-7459-53 | ATOVAQUONE | 7 in 1 CASE | SUSPENSION | 7 | | 6 |
| 0904-7459-53 | ATOVAQUONE | 6 in 1 TRAY | SUSPENSION | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7459 | ATOVAQUONE (ATOVAQUONE ORAL SUSPENSION) SUSPENSION [MAJOR PHARMACEUTICALS] | 5 | Current NDC, 5 package rows | 20241116_73e2297e-7cda-4abf-9fb7-8c67cb5638a3.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 |
|---|
| 0904-7459-25 | 00904745925 | 3 TRAY in 1 CASE (0904-7459-25) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41) | 3 tray | 2024-07-08 | No | No | Current |
| 0904-7459-41 | 00904745941 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 0904-7459-53 | 00904745953 | 7 TRAY in 1 CASE (0904-7459-53) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41) | 7 tray | 2024-07-08 | No | No | Current |