Atovaquone and Proguanil Hydrochloride
- Product NDC
- 10544-909
- 11-digit product format
- 105440909
- Labeler code
- 10544
- Product ID
- 10544-909_13eef6e5-4535-3009-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone and Proguanil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA091211
- Marketing category
- ANDA
- Marketing start
- 2015-03-19
- Marketing end
- 0000-00-00
- Substance
- ATOVAQUONE; PROGUANIL HYDROCHLORIDE
- Active strength
- 250 mg/1; mg/1
- Pharmacologic classes
- Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-909-05 | Atovaquone and Proguanil Hydrochloride | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 1 |
| 10544-909-10 | Atovaquone and Proguanil Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
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 [BLENHEIM PHARMACAL, INC.] | 1 | |
| PROGUANIL HYDROCHLORIDE | ACTIVE INGREDIENT | R71Y86M0WT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| ATOVAQUONE | ACTIVE MOIETY | Y883P1Z2LT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| PROGUANIL | ACTIVE MOIETY | S61K3P7B2V | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-909 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20150417_13eef6e5-4534-3009-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-909-05 | 10544090905 | 5 in 1 BOTTLE | Historical |
| 10544-909-10 | 10544090910 | 10 in 1 BOTTLE | Historical |