Prescription drug · NDA
Eprontia (Topiramate) NDC 52652-9001
Topiramate 25 mg/mL · Solution · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52652-9001-1 | 52652900101 | 473 mL in 1 BOTTLE (52652-9001-1)Marketed from Dec 6, 2021 | |
| 52652-9001-2 | 52652900102 | 1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLEMarketed from Jan 2, 2023 | |
| 52652-9001-3 | 52652900103 | 1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLEMarketed from Jan 2, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eprontia
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 25 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 52652
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214679
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 52652-9001_3feb6452-372c-4c60-8e91-220be75f90b1SPL ID 3feb6452-372c-4c60-8e91-220be75f90b1SPL set ID e2a4df59-fead-4a01-9021-9eda02c48010RxCUI 2586427, 2586433UNII 0H73WJJ391
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452652900101followed by a unit qualifier and the quantityPackage 52652-9001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
EPRONTIA is indicated for: Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ). Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ). 1.1 Monotherapy Epilepsy EPRONTIA is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy EPRONTIA is …
Excerpt only. Read the full label for complete information.
About NDC 52652-9001
- What is NDC 52652-9001?
- 52652-9001 is the product NDC for Eprontia (topiramate), Topiramate 25 mg/mL solution, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eprontia (Topiramate).
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 52652. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eprontia?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.