Topiramate NDC 70710-1039

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-1039Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-1039Add 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
70710-1039-3	70710103903	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-3)Marketed from Jan 17, 2023
70710-1039-9	70710103909	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1039-9)Marketed from Jan 17, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208949
Marketing start: Jan 17, 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 70710-1039_bb736981-167f-4de6-a285-0e840ae37fc7SPL ID bb736981-167f-4de6-a285-0e840ae37fc7SPL set ID a5ca2fce-bd2d-40db-b963-e3ec27c8bf23RxCUI 1494769, 1812419, 1812421, 1812425, 1812427UNII 0H73WJJ391UPC 0370710104139, 0370710104030, 0370710104337, 0370710103934, 0370710104238

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

N470710103903 followed by a unit qualifier and the quantity

Package 70710-1039-03. 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 Apr 16, 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 208949

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

FDA NDC Directory listings under ANDA 208949
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1043
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1041
Topiramate	Topiramate 150 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1042
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1660
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1657
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1658
Topiramate	Topiramate 150 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1659
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1656
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1040