Atovaquone and Proguanil Hydrochloride
- Product NDC
- 68258-1104
- 11-digit product format
- 682581104
- Labeler code
- 68258
- Product ID
- 68258-1104_0f8b0d18-94a9-4e99-a354-0f0fc40039dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone and Proguanil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA091211
- Marketing category
- ANDA
- Marketing start
- 2011-08-18
- 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 |
|---|
| 68258-1104-3 | Atovaquone and Proguanil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 68258-1104-4 | Atovaquone and Proguanil Hydrochloride | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 1 |
| 68258-1104-5 | Atovaquone and Proguanil Hydrochloride | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 1 |
| 68258-1104-6 | Atovaquone and Proguanil Hydrochloride | 16 in 1 BOTTLE | TABLET, FILM COATED | 16 | | 1 |
| 68258-1104-7 | Atovaquone and Proguanil Hydrochloride | 7 in 1 PACKAGE | TABLET, FILM COATED | 7 | | 1 |
| 68258-1104-9 | Atovaquone and Proguanil Hydrochloride | 9 in 1 PACKAGE | TABLET, FILM COATED | 9 | | 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 [DISPENSING SOLUTIONS, INC.] | 1 | |
| PROGUANIL HYDROCHLORIDE | ACTIVE INGREDIENT | R71Y86M0WT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| ATOVAQUONE | ACTIVE MOIETY | Y883P1Z2LT | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| PROGUANIL | ACTIVE MOIETY | S61K3P7B2V | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-1104 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 6 package rows | 20130823_f8659107-ef6b-4142-a4b8-6934aae07f41.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68258-1104-3 | 68258110403 | 30 in 1 BOTTLE | Historical |
| 68258-1104-4 | 68258110404 | 4 in 1 BOTTLE | Historical |
| 68258-1104-5 | 68258110405 | 5 in 1 BOTTLE | Historical |
| 68258-1104-6 | 68258110406 | 16 in 1 BOTTLE | Historical |
| 68258-1104-7 | 68258110407 | 7 in 1 PACKAGE | Historical |
| 68258-1104-9 | 68258110409 | 9 in 1 PACKAGE | Historical |