Atovaquone and Proguanil Hydrochloride
- Product NDC
- 63187-879
- 11-digit product format
- 631870879
- Labeler code
- 63187
- Product ID
- 63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone and Proguanil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091211
- Marketing category
- ANDA
- Marketing start
- 2011-08-18
- Substance
- ATOVAQUONE; PROGUANIL HYDROCHLORIDE
- Active strength
- 250; 100 mg/1; mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atovaquone and Proguanil Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATOVAQUONE | 250 mg/1 |
| PROGUANIL HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y883P1Z2LT, R71Y86M0WT |
| Rxcui | 864675 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-879-16 | Atovaquone and Proguanil Hydrochloride | 16 in 1 BOTTLE | TABLET, FILM COATED | 16 | | 6 |
| 63187-879-24 | Atovaquone and Proguanil Hydrochloride | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-879 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240711_e74b00fc-8743-4e9d-8a83-aab8e531b3ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-879-16 | 63187087916 | 16 TABLET, FILM COATED in 1 BOTTLE (63187-879-16) | 2024-07-08 | | No | No | Current |
| 63187-879-24 | 63187087924 | 24 TABLET, FILM COATED in 1 BOTTLE (63187-879-24) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-879-30 | 63187087930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-879-30) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-879-60 | 63187087960 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-879-60) | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63187-879-90 | 63187087990 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-879-90) | 2017-08-01 | 0000-00-00 | No | No | Current |