What is NDC 65841-648?

65841-648 is the product NDC for topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 65841. 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 65841-648 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-648Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0648Add 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
65841-648-01	65841064801	100 TABLET, FILM COATED in 1 BOTTLE (65841-648-01)Marketed from Mar 27, 2009
65841-648-05	65841064805	500 TABLET, FILM COATED in 1 BOTTLE (65841-648-05)Marketed from Mar 27, 2009
65841-648-14	65841064814	60 TABLET, FILM COATED in 1 BOTTLE (65841-648-14)Marketed from Mar 27, 2009
65841-648-16	65841064816	90 TABLET, FILM COATED in 1 BOTTLE (65841-648-16)Marketed from Mar 27, 2009

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: Tablet, Film coated
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 65841
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
Marketing start: Mar 27, 2009
Listing expires: Dec 31, 2026
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 65841-648_85c62092-3b8c-43af-a980-e2d959e0c341SPL ID 85c62092-3b8c-43af-a980-e2d959e0c341SPL set ID 57016639-89fe-43ad-89c4-5e7a756dddecRxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0368382141149, 0368382139146

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

N465841064801 followed by a unit qualifier and the quantity

Package 65841-0648-01. 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 Aug 14, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 65841-648

What is NDC 65841-648?: 65841-648 is the product NDC for topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 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?: Zydus Lifesciences Limited, NDC labeler code 65841. 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 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	Major Pharmaceuticals	0904-6928
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6929
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5309
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5853
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-806
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-807
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-808
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	AvPAK	50268-809
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-429
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-746
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	St. Mary's Medical Park Pharmacy	60760-075
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-577
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-647
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-649
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-650
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0357
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0375

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