What is NDC 80425-0288?

80425-0288 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 4 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?

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 80425-0288 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0288Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0288Add 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
80425-0288-1	80425028801	30 TABLET, FILM COATED in 1 BOTTLE (80425-0288-1)Marketed from Mar 22, 2023
80425-0288-2	80425028802	60 TABLET, FILM COATED in 1 BOTTLE (80425-0288-2)Marketed from Mar 22, 2023
80425-0288-3	80425028803	90 TABLET, FILM COATED in 1 BOTTLE (80425-0288-3)Marketed from Mar 22, 2023
80425-0288-4	80425028804	270 TABLET, FILM COATED in 1 BOTTLE (80425-0288-4)Marketed from Aug 10, 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, 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 090162
Marketing start: Mar 22, 2023
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 80425-0288_2a9bfe6a-6d66-b262-e063-6294a90a1cf3SPL ID 2a9bfe6a-6d66-b262-e063-6294a90a1cf3SPL set ID f781ada8-f90d-b233-e053-6394a90a87ffRxCUI 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

N480425028801 followed by a unit qualifier and the quantity

Package 80425-0288-01. 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 80425-0288

What is NDC 80425-0288?: 80425-0288 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?: 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?: 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 090162

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

FDA NDC Directory listings under ANDA 090162
Product	Strength	Form · route	Labeler	Product NDC
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-115
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-116
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-117
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-118
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2102
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2203
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7067
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7757
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-752
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-952
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1180
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1202
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1691
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3660
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4760
topiramate	Topiramate 200 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4067
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8817
topiramate	Topiramate 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8828
topiramate	Topiramate 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8835
topiramate	Topiramate 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4515

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