Prescription drug · NDA
Oxtellar XR (Oxcarbazepine) NDC 17772-121
Oxcarbazepine 150 mg/1 · Tablet · Oral · Supernus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17772-121-01 | 17772012101 | 100 TABLET in 1 BOTTLE (17772-121-01)Marketed from Jan 17, 2013 | |
| 17772-121-07 | 17772012107 | 7 TABLET in 1 BOTTLE (17772-121-07)Marketed from Jul 1, 2023 · Sample package | |
| 17772-121-10 | 17772012110 | 5 TABLET in 1 BLISTER PACK (17772-121-10)Marketed from Jan 17, 2013 · Sample package |
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)
- Oxtellar XR
- Generic name (nonproprietary)
- oxcarbazepine
- Active ingredients
- Oxcarbazepine — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Supernus Pharmaceuticals, Inc.NDC labeler code 17772
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202810
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 17772-121_5b887c21-e4f8-1936-e063-6294a90a6db7SPL ID 5b887c21-e4f8-1936-e063-6294a90a6db7
- Pharmacologic class
- Anti-epileptic Agent
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
N417772012101followed by a unit qualifier and the quantityPackage 17772-0121-01. 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 17772-121
- What is NDC 17772-121?
- 17772-121 is the product NDC for Oxtellar XR (oxcarbazepine), Oxcarbazepine 150 mg/1 tablet, listed with the FDA by Supernus Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxtellar XR (Oxcarbazepine).
- What is the active ingredient?
- Oxcarbazepine.
- 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 Oxtellar XR?
- 2 other product NDCs are listed under this name. See all Oxtellar XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxtellar 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) |
|---|---|---|---|---|---|
| Oxtellar XRoxcarbazepine | Oxcarbazepine 300 mg/1 | TabletOral | Supernus Pharmaceuticals, Inc. | 17772-122 | 17772-0122-0117772-0122-0717772-0122-10 |
| Oxtellar XRoxcarbazepine | Oxcarbazepine 600 mg/1 | TabletOral | Supernus Pharmaceuticals, Inc. | 17772-123 | 17772-0123-0117772-0123-0717772-0123-10 |
Other NDCs under NDA 202810
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 |
|---|---|---|---|---|
| Oxtellar XRoxcarbazepine | Oxcarbazepine 300 mg/1 | TabletOral | Supernus Pharmaceuticals, Inc. | 17772-122 |
| Oxtellar XRoxcarbazepine | Oxcarbazepine 600 mg/1 | TabletOral | Supernus Pharmaceuticals, Inc. | 17772-123 |