Atovaquone
- Product NDC
- 69452-252
- 11-digit product format
- 694520252
- Labeler code
- 69452
- Product ID
- 69452-252_4523911f-9d9c-4b0c-e063-6394a90ac76d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA212918
- 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 |
|---|---|
| ATOVAQUONE | 750 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Y883P1Z2LT |
| Rxcui | 308429 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4a3a9d58-de64-b317-9153-f2c3fc3a43c9 | Product name | 8 | 20220517 |
| 7beb5026-9819-5e26-fae7-eca2788430de | Product name | 2 | 20150108 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69452-252-87 | Atovaquone | 210 mL in 1 BOTTLE | SUSPENSION | 210 | 5 | |
| 69452-252-87 | Atovaquone | 1 in 1 CARTON | SUSPENSION | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69452-252-87 | ML - Milliliter | 69452-252 | c5fa876d-5048-4044-9f60-69c4e658e35f | 1 | 2022-03-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308429 | atovaquone 750 MG in 5 mL Oral Suspension | PSN | 16b69156-e5de-c601-e063-6394a90afeae | 5 |
| 308429 | atovaquone 750 MG in 5 mL Oral Suspension | PSN | bff4f4fc-6307-f414-e053-2a95a90ac0de | 5 |
| 308429 | atovaquone 150 MG/ML Oral Suspension | SCD | 16b69156-e5de-c601-e063-6394a90afeae | 5 |
| 308429 | atovaquone 150 MG/ML Oral Suspension | SCD | bff4f4fc-6307-f414-e053-2a95a90ac0de | 5 |
| 308429 | atovaquone 1500 MG per 10 ML Oral Suspension | SY | 16b69156-e5de-c601-e063-6394a90afeae | 5 |
| 308429 | atovaquone 1500 MG per 10 ML Oral Suspension | SY | bff4f4fc-6307-f414-e053-2a95a90ac0de | 5 |
| 308429 | atovaquone 750 MG per 5 ML Oral Suspension | SY | 16b69156-e5de-c601-e063-6394a90afeae | 5 |
| 308429 | atovaquone 750 MG per 5 ML Oral Suspension | SY | bff4f4fc-6307-f414-e053-2a95a90ac0de | 5 |
| 308429 | atovaquone 750 MG in 5 mL Oral Suspension | PSN | ddbfe1a9-df9b-79b0-e053-2995a90acc9b | 4 |
| 308429 | atovaquone 150 MG/ML Oral Suspension | SCD | ddbfe1a9-df9b-79b0-e053-2995a90acc9b | 4 |
| 308429 | atovaquone 1500 MG per 10 ML Oral Suspension | SY | ddbfe1a9-df9b-79b0-e053-2995a90acc9b | 4 |
| 308429 | atovaquone 750 MG per 5 ML Oral Suspension | SY | ddbfe1a9-df9b-79b0-e053-2995a90acc9b | 4 |
| 308429 | atovaquone 750 MG in 5 mL Oral Suspension | PSN | 27d64592-5078-6122-e063-6394a90ae074 | 2 |
| 308429 | atovaquone 150 MG/ML Oral Suspension | SCD | 27d64592-5078-6122-e063-6394a90ae074 | 2 |
| 308429 | atovaquone 1500 MG per 10 ML Oral Suspension | SY | 27d64592-5078-6122-e063-6394a90ae074 | 2 |
| 308429 | atovaquone 750 MG per 5 ML Oral Suspension | SY | 27d64592-5078-6122-e063-6394a90ae074 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69452-252-87 | 69452025287 | 1 BOTTLE in 1 CARTON (69452-252-87) / 210 mL in 1 BOTTLE | 1 bottle | 2021-06-01 | 0000-00-00 | No | No | Current |