Atovaquone
- Product NDC
- 17856-0631
- 11-digit product format
- 178560631
- Labeler code
- 17856
- Product ID
- 17856-0631_34f352d5-bdca-df12-e063-6294a90a54bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA210692
- Marketing category
- ANDA
- Marketing start
- 2018-10-11
- 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 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 |
|---|
| 17856-0631-1 | Atovaquone | 72 in 1 BOX, UNIT-DOSE | SUSPENSION | 72 | | 2 |
| 17856-0631-2 | Atovaquone | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0631 | ATOVAQUONE (ATOVAQUONE) SUSPENSION [ATLANTIC BIOLOGICALS CORP.] | 2 | Current NDC, 2 package rows | 20250514_f99a8a0c-2b42-4da0-8f5a-e963fc619e8b.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 |
|---|
| 17856-0631-1 | 17856063101 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0631-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0631-2) | | 2024-09-04 | No | No | Current |
| 17856-0631-2 | 17856063102 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |