Prescription drug · NDA
Topamax (Topiramate) NDC 50458-645
Topiramate 25 mg/1 · Capsule, Coated pellets · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-645-65 | 5045806456550458064565 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)Marketed from Nov 1, 1998 |
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)
- Topamax
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 25 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020844
- 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 50458-645_d7103f8b-d7c0-4809-8902-85174c517c8eSPL ID d7103f8b-d7c0-4809-8902-85174c517c8e
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
N450458064565followed by a unit qualifier and the quantityPackage 50458-0645-65. 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 50458-645
- What is NDC 50458-645?
- 50458-645 is the product NDC for Topamax (topiramate), Topiramate 25 mg/1 capsule, coated pellets, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topamax (Topiramate).
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topamax?
- 5 other product NDCs are listed under this name. See all Topamax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topamax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topamaxtopiramate | Topiramate 15 mg/1 | Capsule, Coated pelletsOral | Janssen Pharmaceuticals, Inc. | 50458-647 | 50458-0647-65 |
| Topamaxtopiramate | Topiramate 25 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-639 | 50458-0639-65 |
| Topamaxtopiramate | Topiramate 50 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-640 | 50458-0640-65 |
| Topamaxtopiramate | Topiramate 100 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-641 | 50458-0641-65 |
| Topamaxtopiramate | Topiramate 200 mg/1 | Tablet, CoatedOral | Janssen Pharmaceuticals, Inc. | 50458-642 | 50458-0642-65 |
Other NDCs under NDA 020844
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 |
|---|---|---|---|---|
| Topamaxtopiramate | Topiramate 15 mg/1 | Capsule, Coated pelletsOral | Janssen Pharmaceuticals, Inc. | 50458-647 |