Prescription drug · ANDA
topiramate NDC 70518-4515
Topiramate 25 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4515-0 | 70518451500 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-0)Marketed from Nov 4, 2025 | |
| 70518-4515-1 | 70518451501 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4515-1)Marketed from Dec 4, 2025 | |
| 70518-4515-2 | 70518451502 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-2)Marketed from Mar 14, 2026 | |
| 70518-4515-3 | 70518451503 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-3)Marketed from Mar 16, 2026 |
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)
- topiramate
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090162
- 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 70518-4515_5b88213b-13cf-0048-e063-6394a90a51ddSPL ID 5b88213b-13cf-0048-e063-6394a90a51dd
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
N470518451500followed by a unit qualifier and the quantityPackage 70518-4515-00. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 090162
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1202 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9727 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2318 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0214 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-115 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-116 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-117 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-118 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0488 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0495 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7067 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2482 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2480 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2481 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2483 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8817 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-752 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8828 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3660 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8835 |
Showing 20 of 34.