What is NDC 50268-809?

50268-809 is the product NDC for topiramate, Topiramate 200 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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?

278 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 50268-809 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-809Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0809Add 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
50268-809-15	50268080915	50 BLISTER PACK in 1 BOX (50268-809-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-809-11)Marketed from Jun 8, 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 — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
Marketing start: Jun 8, 2026
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 50268-809_53d2fe7d-f398-c878-e063-6394a90a68bdSPL ID 53d2fe7d-f398-c878-e063-6394a90a68bdSPL set ID 53c3f980-f05b-c671-e063-6294a90a77d5RxCUI 151226, 199888, 199889, 199890UNII 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

N450268080915 followed by a unit qualifier and the quantity

Package 50268-0809-15. 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 9, 2026.

Indications (excerpt from the label)

Topiramate 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 tablets and topiramate capsules are 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 Adjun…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-809

What is NDC 50268-809?: 50268-809 is the product NDC for topiramate, Topiramate 200 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, 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?: AvPAK, NDC labeler code 50268. 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?: 278 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 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
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0375	67046-0375-03
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-808	50268-0808-15
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-806	50268-0806-15
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-807	50268-0807-15
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1180	67046-1180-03

All 279 topiramate NDCs

Other NDCs under ANDA 078235

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

FDA NDC Directory listings under ANDA 078235
Product	Strength	Form · route	Labeler	Product NDC
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1684
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0398
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4877
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-746
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-075
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-140
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-138
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-139
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-141
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-808
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-806
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-807
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1718
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-848
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7142
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7146
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0233
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-429
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-577
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-649

Showing 20 of 39.