atovaquone
- Product NDC
- 68462-421
- 11-digit product format
- 684620421
- Labeler code
- 68462
- Product ID
- 68462-421_b221c446-0200-4c11-bd0c-ff9ec502bc19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA209685
- Marketing category
- ANDA
- Marketing start
- 2017-12-31
- 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 |
|---|
| 68462-421-21 | atovaquone | 210 mL in 1 BOTTLE | SUSPENSION | 210 | | 9 |
| 68462-421-69 | atovaquone | 42 in 1 CARTON | SUSPENSION | 42 | | 9 |
| 68462-421-69 | atovaquone | 5 mL in 1 POUCH | SUSPENSION | 5 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-421 | ATOVAQUONE SUSPENSION [GLENMARK PHARMACEUTICALS INC., USA] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240103_9045ba6f-938e-4717-bfa2-a3efe52f04cd.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 |
|---|
| 68462-421-21 | 68462042121 | 210 mL in 1 BOTTLE (68462-421-21) | 210 ml | 2017-12-31 | 0000-00-00 | No | No | Current |
| 68462-421-69 | 68462042169 | 42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH | 42 pouch | 2017-12-31 | 0000-00-00 | No | No | Current |