What is NDC 81033-035?

81033-035 is the product NDC for Topiramate, Topiramate 25 mg/mL solution, listed with the FDA by Kesin Pharma. It has 3 package NDCs, shown above in 10- and 11-digit form.

Kesin Pharma, NDC labeler code 81033. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Topiramate?

276 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topiramate NDC 81033-035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81033-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81033-0035Add 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
81033-035-14	81033003514	10 CUP, UNIT-DOSE in 1 CARTON (81033-035-14) / 4 mL in 1 CUP, UNIT-DOSE (81033-035-04)Marketed from Jul 1, 2026
81033-035-15	81033003515	10 CUP, UNIT-DOSE in 1 CARTON (81033-035-15) / 6 mL in 1 CUP, UNIT-DOSE (81033-035-06)Marketed from Jul 1, 2026
81033-035-16	81033003516	10 CUP, UNIT-DOSE in 1 CARTON (81033-035-16) / 8 mL in 1 CUP, UNIT-DOSE (81033-035-08)Marketed from Jul 1, 2026

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/mL
Dosage form: Solution
Route: Oral
Labeler: Kesin PharmaNDC labeler code 81033
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217795
Marketing start: Jul 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 81033-035_54636499-ba0d-daf9-e063-6394a90a0966SPL ID 54636499-ba0d-daf9-e063-6394a90a0966SPL set ID 4e914420-a65b-98ba-e063-6394a90a14c4RxCUI 2586427UNII 0H73WJJ391

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

N481033003514 followed by a unit qualifier and the quantity

Package 81033-0035-14. 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 Jun 16, 2026.

Indications (excerpt from the label)

Topiramate oral solution 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 Topiramate oral solution 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 Adj…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81033-035

What is NDC 81033-035?: 81033-035 is the product NDC for Topiramate, Topiramate 25 mg/mL solution, listed with the FDA by Kesin Pharma. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topiramate.
What is the active ingredient?: Topiramate.
Who is the labeler?: Kesin Pharma, NDC labeler code 81033. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topiramate?: 276 other product NDCs are listed under this name. See all Topiramate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Topiramate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Topiramate	Topiramate 25 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-325	27808-0325-01
Topiramate	Topiramate 50 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-326	27808-0326-01
Topiramate	Topiramate 100 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-327	27808-0327-01
Topiramate	Topiramate 150 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-328	27808-0328-01
Topiramate	Topiramate 200 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-329	27808-0329-01
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-952	60760-0952-60
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0357	67046-0357-03
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1691	67046-1691-03
Topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-079	87441-0079-01
Topiramate	Topiramate 100 mg/1	TabletOral	Coupler LLC	67046-1688	67046-1688-03

All 277 Topiramate NDCs

Other NDCs under ANDA 217795

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

FDA NDC Directory listings under ANDA 217795
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 25 mg/mL	SolutionOral	Ascend Laboratories, LLC	67877-833