Atovaquone and Proguanil Hydrochloride
- Product NDC
- 43063-393
- 11-digit product format
- 430630393
- Labeler code
- 43063
- Product ID
- 43063-393_e6884998-d920-63e9-e053-2a95a90abda1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone and Proguanil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA091211
- Marketing category
- ANDA
- Marketing start
- 2011-09-15
- 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
DailyMed Product Concepts#
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 [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| PROGUANIL HYDROCHLORIDE | ACTIVE INGREDIENT | R71Y86M0WT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| ATOVAQUONE | ACTIVE MOIETY | Y883P1Z2LT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| PROGUANIL | ACTIVE MOIETY | S61K3P7B2V | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-393 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 16 | Legacy NDC | 20241012_a79fb027-66a6-47c8-9ee7-ce9367e9ec6e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-393-14 | 43063039314 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-14) | 2012-07-02 | 0000-00-00 | No | No | Current |
| 43063-393-20 | 43063039320 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-20) | 2012-07-02 | 0000-00-00 | No | No | Current |