Atovaquone
- Product NDC
- 68180-282
- 11-digit product format
- 681800282
- Labeler code
- 68180
- Product ID
- 68180-282_c674ef94-b52d-47f3-807b-e7cb64c11ca2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA209105
- Marketing category
- ANDA
- Marketing start
- 2018-11-07
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 68180-282 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68180-282 | 68180-282-01 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A209105-001 | ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION / ORAL | | | 2018-09-11 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-282-01 | 68180028201 | 1 BOTTLE in 1 CARTON (68180-282-01) > 210 mL in 1 BOTTLE | 1 bottle | 2018-11-07 | 0000-00-00 | No | No | Current |