Topiramate NDC 10370-366

NDC codes

FDA NDC Directory

Product NDC (as listed)10370-366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10370-0366Add 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
10370-366-01	10370036601	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-366-01)Marketed from May 26, 2023
10370-366-11	10370036611	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-366-11)Marketed from May 26, 2023

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 — 50 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Par Health USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205976
Marketing start: May 26, 2023
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 10370-366_3ea04de6-6c56-44ab-ba90-def5e0468ba5SPL ID 3ea04de6-6c56-44ab-ba90-def5e0468ba5SPL set ID 11e0924b-fbee-4ec4-b1e4-22d7683b21eeRxCUI 1436239, 1437278, 1437283UNII 0H73WJJ391UPC 0310370365112, 0310370367116, 0310370366119

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

N410370036601 followed by a unit qualifier and the quantity

Package 10370-0366-01. 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

Current FDA label (SPL), effective May 27, 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 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 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 6 years of age an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205976

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

FDA NDC Directory listings under ANDA 205976
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Par Health USA, LLC	10370-365
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Par Health USA, LLC	10370-367
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Par Health USA, LLC	10370-368