Atovaquone
- Product NDC
- 0121-0956
- 11-digit product format
- 001210956
- Labeler code
- 0121
- Product ID
- 0121-0956_0145c97d-2d5e-4fcd-ae76-85e4ae946350
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA214272
- Marketing category
- ANDA
- Marketing start
- 2025-04-04
- Substance
- ATOVAQUONE
- Active strength
- 750 mg/5mL
- Pharmacologic classes
- Antimalarial [EPC], Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atovaquone
- Listing expiration
- 2027-12-31
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 |
|---|
| 0121-0956-08 | Atovaquone | 210 mL in 1 BOTTLE | SUSPENSION | 210 | | 13 |
| 0121-0956-08 | Atovaquone | 1 in 1 CARTON | SUSPENSION | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0956 | ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 12 | Current NDC, 2 package rows | 20250406_df6086d3-6100-422a-bf23-e9610027749b.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 |
|---|
| 0121-0956-08 | 00121095608 | 1 BOTTLE in 1 CARTON (0121-0956-08) / 210 mL in 1 BOTTLE | 1 bottle | 2025-04-04 | No | No | Historical |