Atovaquone
- Product NDC
- 17856-8631
- 11-digit product format
- 178568631
- Labeler code
- 17856
- Product ID
- 17856-8631_40331587-a465-4ac5-e063-6294a90a7ec6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA210692
- Marketing category
- ANDA
- Marketing start
- 2018-10-11
- 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 |
|---|
| 17856-8631-1 | Atovaquone | 50 in 1 BOX, UNIT-DOSE | SUSPENSION | 50 | | 1 |
| 17856-8631-1 | Atovaquone | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-8631-1 | 17856863101 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-8631-1) / 5 mL in 1 CUP, UNIT-DOSE | 2025-10-01 | No | No | Historical |