Prescription drug · NDA
Qudexy XR (Topiramate) NDC 0245-1075
Topiramate 150 mg/1 · Capsule, Extended release · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-1075-30 | 00245107530 | 1 BOTTLE in 1 CARTON (0245-1075-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 11, 2014 | |
| 0245-1075-90 | 00245107590 | 1 BOTTLE in 1 CARTON (0245-1075-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 11, 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)
- Qudexy XRSuffix: XR
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 150 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0245
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication 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 0245-1075_5cfd7234-5efc-4cb8-b69c-7e68b9f1a94fSPL ID 5cfd7234-5efc-4cb8-b69c-7e68b9f1a94fSPL set ID 46f54677-3a22-4c38-9b92-923020164e15RxCUI 1494766, 1494769, 1494771, 1494775, 1494778, 1494781, 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
N400245107530followed by a unit qualifier and the quantityPackage 00245-1075-30. 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)
QUDEXY XR is 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 QUDEXY XR is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy QUDEXY XR is…
Excerpt only. Read the full label for complete information.
About NDC 0245-1075
- What is NDC 0245-1075?
- 0245-1075 is the product NDC for Qudexy XR (topiramate), Topiramate 150 mg/1 capsule, extended release, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qudexy XR (Topiramate).
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qudexy XR?
- 4 other product NDCs are listed under this name. See all Qudexy XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Qudexy XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Qudexy XRtopiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1071 | 00245-1071-3000245-1071-90 |
| Qudexy XRtopiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1072 | 00245-1072-3000245-1072-90 |
| Qudexy XRtopiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1073 | 00245-1073-3000245-1073-90 |
| Qudexy XRtopiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0245-1074 | 00245-1074-3000245-1074-90 |
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 |
| 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 200 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-1073 |
| 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 |