Atovaquone and Proguanil Hydrochloride
- Product NDC
- 68001-245
- 11-digit product format
- 680010245
- Labeler code
- 68001
- Product ID
- 68001-245_eff0fdfe-695c-4e62-e053-2a95a90ab50f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone and Proguanil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA091211
- Marketing category
- ANDA
- Marketing start
- 2014-03-13
- 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
- 2027-12-31
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 |
|---|
| 68001-245-00 | Atovaquone and Proguanil Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 68001-245-14 | Atovaquone and Proguanil Hydrochloride | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 8 |
| 68001-245-15 | Atovaquone and Proguanil Hydrochloride | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATOVAQUONE | ACTIVE INGREDIENT | Y883P1Z2LT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| PROGUANIL HYDROCHLORIDE | ACTIVE INGREDIENT | R71Y86M0WT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| ATOVAQUONE | ACTIVE MOIETY | Y883P1Z2LT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| PROGUANIL | ACTIVE MOIETY | S61K3P7B2V | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-245 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 7 | Current NDC, Legacy NDC, 3 package rows | 20221217_ad25ab65-42aa-48f6-b5ed-247f3685d5bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68001-245-00 | 68001024500 | 100 TABLET, FILM COATED in 1 BOTTLE (68001-245-00) | | 2014-03-13 | 0000-00-00 | No | No | Current |
| 68001-245-14 | 68001024514 | 12 in 1 BLISTER PACK | | | | | | Historical |
| 68001-245-15 | 68001024515 | 2 BLISTER PACK in 1 CARTON (68001-245-15) / 12 TABLET, FILM COATED in 1 BLISTER PACK (68001-245-14) | 2 blister pack | 2014-03-13 | 0000-00-00 | No | No | Current |