Atovaquone and Proguanil HCl
- Product NDC
- 43063-522
- 11-digit product format
- 430630522
- Labeler code
- 43063
- Product ID
- 43063-522_e71787c0-36b5-1e75-e053-2995a90a8fd1
- 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 AUTHORIZED GENERIC
- Marketing start
- 2012-07-27
- 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 |
|---|
| 43063-522-07 | 43063052207 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-07) | 2015-01-30 | 0000-00-00 | No | No | Current |
| 43063-522-14 | 43063052214 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-14) | 2015-01-30 | 0000-00-00 | No | No | Current |
| 43063-522-20 | 43063052220 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-20) | 2015-01-30 | 0000-00-00 | No | No | Current |
| 43063-522-24 | 43063052224 | 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-24) | 2015-01-30 | 0000-00-00 | No | No | Current |
| 43063-522-68 | 43063052268 | 190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-68) | 2015-01-30 | 0000-00-00 | No | No | Current |
| 43063-522-69 | 43063052269 | 280 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-69) | 2015-01-30 | 0000-00-00 | No | No | Current |
| 43063-522-73 | 43063052273 | 375 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-522-73) | 2015-01-30 | 0000-00-00 | No | No | Current |