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 | 7051845150070518451500 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-0)Marketed from Nov 4, 2025 | |
| 70518-4515-1 | 7051845150170518451501 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4515-1)Marketed from Dec 4, 2025 | |
| 70518-4515-2 | 7051845150270518451502 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-2)Marketed from Mar 14, 2026 | |
| 70518-4515-3 | 7051845150370518451503 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-3)Marketed from Mar 16, 2026 | |
| 70518-4515-4 | 7051845150470518451504 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4515-4)Marketed from Oct 6, 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.NDC labeler code 70518
- 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_5d31428a-1afd-1b5c-e063-6294a90affd7SPL ID 5d31428a-1afd-1b5c-e063-6294a90affd7
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.
About NDC 70518-4515
- What is NDC 70518-4515?
- 70518-4515 is the product NDC for topiramate, Topiramate 25 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topiramate.
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topiramate?
- 277 other product NDCs are listed under this name. See all topiramate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topiramate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-325 | 27808-0325-01 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-326 | 27808-0326-01 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-327 | 27808-0327-01 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-328 | 27808-0328-01 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-329 | 27808-0329-01 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-952 | 60760-0952-60 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0357 | 67046-0357-03 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1691 | 67046-1691-03 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-079 | 87441-0079-01 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Coupler LLC | 67046-1688 | 67046-1688-03 |
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 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 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2102 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2203 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7067 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7757 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-752 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-952 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1180 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1202 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1691 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3660 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4760 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4067 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8817 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8828 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8835 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-187 |
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