Topamax (topiramate) NDC 50458-641

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-641Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0641Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50458-641-65	50458064165	60 TABLET, COATED in 1 BOTTLE (50458-641-65)Marketed from Jan 1, 1997

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 — 100 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Janssen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020505
Marketing start: Jan 1, 1997
Listing expires: Dec 31, 2027
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 50458-641_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8SPL ID 1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8SPL set ID 21628112-0c47-11df-95b3-498d55d89593RxCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, 845478, 845479UNII 0H73WJJ391UPC 0350458647655, 0350458641653, 0350458645651, 0350458639650, 0350458640656, 0350458642650

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

N450458064165 followed by a unit qualifier and the quantity

Package 50458-0641-65. 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

Current FDA label (SPL), effective Mar 12, 2026.

Indications (excerpt from the label)

TOPAMAX 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 TOPAMAX 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 TOPAMAX is indic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020505

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020505
Product	Strength	Form · route	Labeler	Product NDC
Topamaxtopiramate	Topiramate 50 mg/1	Tablet, CoatedOral	Janssen Pharmaceuticals, Inc.	50458-640
Topamaxtopiramate	Topiramate 25 mg/1	Tablet, CoatedOral	Janssen Pharmaceuticals, Inc.	50458-639
Topamaxtopiramate	Topiramate 200 mg/1	Tablet, CoatedOral	Janssen Pharmaceuticals, Inc.	50458-642