Prescription drug · NDA
Trokendi XR (Topiramate) NDC 17772-103
Topiramate 100 mg/1 · Capsule, Extended release · Oral · Supernus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17772-103-01 | 17772010301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)Marketed from Aug 16, 2013 | |
| 17772-103-07 | 17772010307 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07)Marketed from Jun 23, 2020 · Sample package | |
| 17772-103-10 | 17772010310 | 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10)Marketed from Aug 16, 2013 · Sample package | |
| 17772-103-12 | 17772010312 | 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12)Marketed from Aug 16, 2013 · Sample package | |
| 17772-103-30 | 17772010330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30)Marketed from Aug 16, 2013 |
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)
- Trokendi XR
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Supernus Pharmaceuticals, Inc.NDC labeler code 17772
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201635
- 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 17772-103_5b8a1778-ed48-a5a4-e063-6394a90a581cSPL ID 5b8a1778-ed48-a5a4-e063-6394a90a581c
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
N417772010301followed by a unit qualifier and the quantityPackage 17772-0103-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 17772-103
- What is NDC 17772-103?
- 17772-103 is the product NDC for Trokendi XR (topiramate), Topiramate 100 mg/1 capsule, extended release, listed with the FDA by Supernus Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trokendi XR (Topiramate).
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- Supernus Pharmaceuticals, Inc., NDC labeler code 17772. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trokendi XR?
- 3 other product NDCs are listed under this name. See all Trokendi XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trokendi 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) |
|---|---|---|---|---|---|
| Trokendi XRtopiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc. | 17772-101 | 17772-0101-0117772-0101-0717772-0101-10+2 more |
| Trokendi XRtopiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc. | 17772-102 | 17772-0102-0117772-0102-0717772-0102-10+2 more |
| Trokendi XRtopiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc. | 17772-104 | 17772-0104-0117772-0104-0717772-0104-10+2 more |
Other NDCs under NDA 201635
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 |
|---|---|---|---|---|
| Trokendi XRtopiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc. | 17772-101 |
| Trokendi XRtopiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc. | 17772-102 |
| Trokendi XRtopiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Supernus Pharmaceuticals, Inc. | 17772-104 |