Prescription drug · ANDA
Topiramate NDC 27241-297
Topiramate 50 mg/1 · Capsule, Extended release · Oral · Ajanta Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27241-297-30 | 27241029730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-297-30)Marketed from Sep 2, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 50 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Ajanta Pharma USA Inc.NDC labeler code 27241
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219564
- 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 27241-297_a64af809-588a-4986-93e6-99fe5a7537cfSPL ID a64af809-588a-4986-93e6-99fe5a7537cf
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
N427241029730followed by a unit qualifier and the quantityPackage 27241-0297-30. 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 27241-297
- What is NDC 27241-297?
- 27241-297 is the product NDC for Topiramate, Topiramate 50 mg/1 capsule, extended release, listed with the FDA by Ajanta Pharma USA Inc.. It has 1 package NDC, 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?
- Ajanta Pharma USA Inc., NDC labeler code 27241. 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?
- 278 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 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 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0375 | 67046-0375-03 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-806 | 50268-0806-15 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-807 | 50268-0807-15 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-808 | 50268-0808-15 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-809 | 50268-0809-15 |
Other NDCs under ANDA 219564
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 100 mg/1 | Capsule, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-298 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-296 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-299 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Ajanta Pharma USA Inc. | 27241-300 |