Topiramate NDC 69680-177

NDC codes

FDA NDC Directory

Product NDC (as listed)69680-177Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69680-0177Add 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
69680-177-30	69680017730	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-177-30)Marketed from Apr 7, 2025

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): Topiramate
Generic name (nonproprietary): topiramate
Active ingredients: Topiramate — 25 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Vitruvias Therapeutics, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215638
Marketing start: Apr 7, 2025
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 69680-177_0a7f1a1b-961e-4458-8312-7920a78e4dbeSPL ID 0a7f1a1b-961e-4458-8312-7920a78e4dbeSPL set ID a9d7c5ef-daf9-4f97-8673-7f4a2007f408RxCUI 1494769, 1812419, 1812421, 1812425, 1812427UNII 0H73WJJ391UPC 0369680179308, 0369680177304, 0369680178301, 0369680181301, 0369680180304

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

N469680017730 followed by a unit qualifier and the quantity

Package 69680-0177-30. 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 May 7, 2026.

Indications (excerpt from the label)

Topiramate extended-release capsules are 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 Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215638

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

FDA NDC Directory listings under ANDA 215638
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-178
Topiramate	Topiramate 150 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-180
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-179
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-181