Topiramate NDC 42291-958

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-958Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0958Add 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
42291-958-30	42291095830	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-958-30)Marketed from Oct 30, 2024

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 — 200 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206210
Marketing start: Oct 30, 2024
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 42291-958_48c104bb-d8d9-2940-e063-6394a90aeab3SPL ID 48c104bb-d8d9-2940-e063-6394a90aeab3SPL set ID 25b377f7-ea89-fb56-e063-6394a90a239dRxCUI 1436239, 1437278, 1437283, 1437288UNII 0H73WJJ391UPC 0342291958302, 0342291957305, 0342291956308

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

N442291095830 followed by a unit qualifier and the quantity

Package 42291-0958-30. 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 Jan 19, 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 206210

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

FDA NDC Directory listings under ANDA 206210
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	AvKARE	42291-956
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	AvKARE	42291-955
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	AvKARE	42291-957
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-2356
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-2357
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-2358
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Teva Pharmaceuticals, Inc.	0480-2359