NDC 52652-9001 – Eprontia
Topiramate 25 mg/mL · Solution · Oral
Product NDC52652-9001
Product details
- Brand name
- Eprontia
- Generic name
- Topiramate
- Labeler
- Azurity Pharmaceuticals, Inc.
- Dosage form
- Solution
- Route
- Oral
- Marketing category
- NDA · NDA214679
- Marketed since
- December 6, 2021
- Listing expires
- December 31, 2027
Active ingredients
- Topiramate 25 mg/mL
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 52652-9001-1 | 473 mL in 1 BOTTLE (52652-9001-1) | Dec 6, 2021 |
| 52652-9001-2 | 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE | Jan 2, 2023 |
| 52652-9001-3 | 1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE | Jan 2, 2023 |
Recalls mentioning this NDC
- D-0213-2024 Jan 10, 2024 · Class III
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.