What is NDC 80425-0092?

80425-0092 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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?

277 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 80425-0092 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0092Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0092Add 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
80425-0092-1	8042500920180425009201	30 TABLET, FILM COATED in 1 BOTTLE (80425-0092-1)Marketed from Mar 27, 2009
80425-0092-2	8042500920280425009202	60 TABLET, FILM COATED in 1 BOTTLE (80425-0092-2)Marketed from Mar 27, 2009
80425-0092-3	8042500920380425009203	90 TABLET, FILM COATED in 1 BOTTLE (80425-0092-3)Marketed from Aug 14, 2024

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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
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 80425-0092_1faa2b61-b53d-b7b0-e063-6394a90a8712SPL ID 1faa2b61-b53d-b7b0-e063-6394a90a8712SPL set ID b353e7fb-b976-96d8-e053-2995a90a110aRxCUI 151226UNII 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

N480425009201 followed by a unit qualifier and the quantity

Package 80425-0092-01. 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.

Indications (excerpt from the label)

1. Indications and Usage Section 1 INDICATIONS AND USAGE 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 Adjunctive Therapy Epilepsy Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. 1.3 Migraine Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 year…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0092

What is NDC 80425-0092?: 80425-0092 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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?: 277 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 278 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 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3926
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 50 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-648
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

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