MALARONE
- Product NDC
- 55289-747
- 11-digit product format
- 552890747
- Labeler code
- 55289
- Product ID
- 55289-747_e2382734-ff7e-3075-e053-2995a90a958d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atovaquone and proguanil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- NDA021078
- Marketing category
- NDA
- Marketing start
- 2000-07-26
- Marketing end
- 0000-00-00
- Substance
- ATOVAQUONE; PROGUANIL HYDROCHLORIDE
- Active strength
- 250 mg/1; mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-747-20 | 55289074720 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-747-20) | 2011-12-15 | 0000-00-00 | No | No | Current |