Prescription drug · ANDA
Topiramate NDC 72603-124
Topiramate 200 mg/1 · Capsule, Extended release · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-124-01 | 72603012401 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72603-124-01)Marketed from Jan 1, 2023 |
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 — 200 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210278
- 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 72603-124_a1168608-1b38-4cbe-92b2-dee1771593e1SPL ID a1168608-1b38-4cbe-92b2-dee1771593e1SPL set ID b5f8da43-6daf-413c-9dcd-363617973738RxCUI 1494769, 1812419, 1812421, 1812425, 1812427UNII 0H73WJJ391UPC 0372603120011, 0372603123012, 0372603122015, 0372603121018, 0372603124019
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
N472603012401followed by a unit qualifier and the quantityPackage 72603-0124-01. 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)
Topiramate extended-release capsules are 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 Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210278
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 | NorthStar RxLLC | 72603-122 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-120 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-121 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-123 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-370 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-374 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-371 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-372 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-373 |