Prescription drug · NDA AUTHORIZED GENERIC
Topiramate NDC 0832-1073
Topiramate 200 mg/1 · Capsule, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1073-15 | 00832107315 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-1073-15)Marketed from Jul 7, 2014 | |
| 0832-1073-30 | 00832107330 | 1 BOTTLE in 1 CARTON (0832-1073-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 7, 2014 | |
| 0832-1073-90 | 00832107390 | 1 BOTTLE in 1 CARTON (0832-1073-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 7, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 205122
- 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 0832-1073_1be5841a-e872-475c-bfe9-859be4ba4001SPL ID 1be5841a-e872-475c-bfe9-859be4ba4001SPL set ID 691d276c-9cc1-4d39-828f-0f44d7ef6328RxCUI 1494769, 1812419, 1812421, 1812425, 1812427UNII 0H73WJJ391
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
N400832107315followed by a unit qualifier and the quantityPackage 00832-1073-15. 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 age an…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205122
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 |
|---|---|---|---|---|
| Qudexy XRtopiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1071 |
| Qudexy XRtopiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1072 |
| Qudexy XRtopiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1073 |
| Qudexy XRtopiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1074 |
| Qudexy XRtopiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1075 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-1071 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-1072 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-1074 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-1075 |