ATOVAQUONE
- Product NDC
- 70748-299
- 11-digit product format
- 707480299
- Labeler code
- 70748
- Product ID
- 70748-299_26a9360d-7db4-42fe-b9d2-ecddfe369d2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATOVAQUONE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA210692
- Marketing category
- ANDA
- Marketing start
- 2021-06-01
- 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 |
|---|
| 70748-299-01 | ATOVAQUONE | 210 mL in 1 BOTTLE | SUSPENSION | 210 | | 1 |
| 70748-299-01 | ATOVAQUONE | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-299 | ATOVAQUONE SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210601_03ddcc33-729c-4d46-ae6b-2ee47978ba16.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70748-299-01 | 70748029901 | 1 BOTTLE in 1 CARTON (70748-299-01) / 210 mL in 1 BOTTLE | 1 bottle | 2021-06-01 | 0000-00-00 | No | No | Current |