What is NDC 80425-0208?

80425-0208 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, 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 80425-0208 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0208Add 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
80425-0208-1	8042502080180425020801	60 TABLET in 1 BOTTLE (80425-0208-1)Marketed from Feb 25, 2024
80425-0208-2	8042502080280425020802	30 TABLET in 1 BOTTLE (80425-0208-2)Marketed from Mar 31, 2023
80425-0208-3	8042502080380425020803	90 TABLET in 1 BOTTLE (80425-0208-3)Marketed from Mar 31, 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: Tablet
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 076343
Marketing start: Jun 14, 2014
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 80425-0208_2a99c0c8-93bb-9e14-e063-6394a90a332bSPL ID 2a99c0c8-93bb-9e14-e063-6394a90a332bSPL set ID eca774cf-2e4e-7642-e053-2a95a90a847dRxCUI 199888UNII 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

N480425020801 followed by a unit qualifier and the quantity

Package 80425-0208-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

1. Indications and Usage 1.1 Monotherapy Epilepsy Topiramate tablets 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 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 are indicated for the preventive treatment of migraine in patients 12 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0208

What is NDC 80425-0208?: 80425-0208 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, 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 076343

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

FDA NDC Directory listings under ANDA 076343
Product	Strength	Form · route	Labeler	Product NDC
Topiramate	Topiramate 25 mg/1	TabletOral	A-S Medication Solutions	50090-4614
Topiramate	Topiramate 200 mg/1	TabletOral	Proficient Rx LP	63187-963
Topiramate	Topiramate 100 mg/1	TabletOral	Coupler LLC	67046-1688
Topiramate	Topiramate 25 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-1971
Topiramate	Topiramate 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-0625
Topiramate	Topiramate 50 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0195
Topiramate	Topiramate 50 mg/1	TabletOral	A-S Medication Solutions	50090-6828
Topiramate	Topiramate 100 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3088
Topiramate	Topiramate 25 mg/1	TabletOral	A-S Medication Solutions	50090-6827
Topiramate	Topiramate 50 mg/1	TabletOral	A-S Medication Solutions	50090-3461
Topiramate	Topiramate 100 mg/1	TabletOral	Proficient Rx LP	63187-696
Topiramate	Topiramate 200 mg/1	TabletOral	Asclemed USA, Inc.	76420-280
Topiramate	Topiramate 50 mg/1	TabletOral	Asclemed USA, Inc.	76420-276
Topiramate	Topiramate 25 mg/1	TabletOral	Asclemed USA, Inc.	76420-278
Topiramate	Topiramate 100 mg/1	TabletOral	Asclemed USA, Inc.	76420-279
Topiramate	Topiramate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-0337
Topiramate	Topiramate 100 mg/1	TabletOral	C	61919-213
Topiramate	Topiramate 50 mg/1	TabletOral	Northwind Health Company, LLC	51655-606
Topiramate	Topiramate 50 mg/1	TabletOral	Proficient Rx LP	63187-758
Topiramate	Topiramate 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-734

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