Atovaquone
- Product NDC
- 0121-0898
- 11-digit product format
- 001210898
- Labeler code
- 0121
- Product ID
- 0121-0898_0d67fa4c-b36a-4d81-8e7d-a661db92df22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC
- Application
- ANDA210692
- Marketing category
- ANDA
- Marketing start
- 2018-10-11
- Marketing end
- 0000-00-00
- Substance
- ATOVAQUONE
- Active strength
- 750 mg/5mL
- Pharmacologic classes
- Antimalarial [EPC], Antiprotozoal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0898 | ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 11 | Legacy NDC | 20250109_ba4bea2e-aeec-084d-e053-2a95a90a04d4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0898-18 | 00121089818 | 3 TRAY in 1 CASE (0121-0898-18) > 6 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05) | 3 tray | 2021-02-05 | 0000-00-00 | No | No | Current |
| 0121-0898-42 | 00121089842 | 7 TRAY in 1 CASE (0121-0898-42) > 6 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0898-05) | 7 tray | 2021-02-05 | 0000-00-00 | No | No | Current |