Prescription drug · ANDA
Topiramate NDC 42291-955
Topiramate 25 mg/1 · Capsule, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-955-30 | 42291095530 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-955-30)Marketed from Oct 30, 2024 |
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 — 25 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206210
- 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 42291-955_48c104bb-d8d9-2940-e063-6394a90aeab3SPL ID 48c104bb-d8d9-2940-e063-6394a90aeab3SPL set ID 25b377f7-ea89-fb56-e063-6394a90a239dRxCUI 1436239, 1437278, 1437283, 1437288UNII 0H73WJJ391UPC 0342291958302, 0342291957305, 0342291956308
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
N442291095530followed by a unit qualifier and the quantityPackage 42291-0955-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Topiramate extended-release capsules are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 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 Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age an…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206210
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 | Capsule, Extended releaseOral | AvKARE | 42291-956 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-957 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-958 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals, Inc. | 0480-2356 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals, Inc. | 0480-2357 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals, Inc. | 0480-2358 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals, Inc. | 0480-2359 |