Eprontia
- Product NDC
- 52652-9001
- 11-digit product format
- 526529001
- Labeler code
- 52652
- Product ID
- 52652-9001_3feb6452-372c-4c60-8e91-220be75f90b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA214679
- Marketing category
- NDA
- Marketing start
- 2021-12-06
- Substance
- TOPIRAMATE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eprontia
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 2586427, 2586433 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52652-9001-1 | Eprontia | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 8 |
| 52652-9001-2 | Eprontia | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
| 52652-9001-2 | Eprontia | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 8 |
| 52652-9001-3 | Eprontia | 1 in 1 CARTON | SOLUTION | 1 | | 8 |
| 52652-9001-3 | Eprontia | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52652-9001 | EPRONTIA (TOPIRAMATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20250323_e2a4df59-fead-4a01-9021-9eda02c48010.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 |
|---|
| 52652-9001-1 | 52652900101 | 473 mL in 1 BOTTLE (52652-9001-1) | 473 ml | 2021-12-06 | 0000-00-00 | No | No | Current |
| 52652-9001-2 | 52652900102 | 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE | 1 bottle | 2023-01-02 | 0000-00-00 | No | No | Current |
| 52652-9001-3 | 52652900103 | 1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE | 1 bottle | 2023-01-02 | 0000-00-00 | No | No | Current |