ATOVAQUONE
- Product NDC
- 65162-693
- 11-digit product format
- 651620693
- Labeler code
- 65162
- Product ID
- 65162-693_ea283214-c6a9-42be-a5fe-b35a74aa56af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ATOVAQUONE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA202960
- Marketing category
- ANDA
- Marketing start
- 2011-02-09
- 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 |
|---|---|
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-693-88 | ATOVAQUONE | 1 in 1 CARTON | SUSPENSION | 1 | 24 | |
| 65162-693-88 | ATOVAQUONE | 210 mL in 1 BOTTLE | SUSPENSION | 210 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-693-88 | ML - Milliliter | 65162-693 | cc070f49-aa4a-4bf6-91cf-02a1907221f5 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ATOVAQUONE | ACTIVE INGREDIENT | Y883P1Z2LT | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| ATOVAQUONE | ACTIVE MOIETY | Y883P1Z2LT | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | ATOVAQUONE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308429 | atovaquone 750 MG in 5 mL Oral Suspension | PSN | b7398fcf-522a-488a-8dd6-051561f62804 | 24 |
| 308429 | atovaquone 150 MG/ML Oral Suspension | SCD | b7398fcf-522a-488a-8dd6-051561f62804 | 24 |
| 308429 | atovaquone 1500 MG per 10 ML Oral Suspension | SY | b7398fcf-522a-488a-8dd6-051561f62804 | 24 |
| 308429 | atovaquone 750 MG per 5 ML Oral Suspension | SY | b7398fcf-522a-488a-8dd6-051561f62804 | 24 |
| 308429 | atovaquone 750 MG in 5 mL Oral Suspension | PSN | 4124ad97-f6b9-8afb-e063-6294a90ab970 | 1 |
| 308429 | atovaquone 150 MG/ML Oral Suspension | SCD | 4124ad97-f6b9-8afb-e063-6294a90ab970 | 1 |
| 308429 | atovaquone 1500 MG per 10 ML Oral Suspension | SY | 4124ad97-f6b9-8afb-e063-6294a90ab970 | 1 |
| 308429 | atovaquone 750 MG per 5 ML Oral Suspension | SY | 4124ad97-f6b9-8afb-e063-6294a90ab970 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65162-693-88 | 65162069388 | 1 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLE | 1 bottle | 2011-02-09 | 0000-00-00 | No | No | Current |