What is NDC 80425-0258?

80425-0258 is the product NDC for Sumatriptan, Sumatriptan succinate 100 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, 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 Sumatriptan?

75 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sumatriptan NDC 80425-0258 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0258Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0258Add 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
80425-0258-1	8042502580180425025801	1 BLISTER PACK in 1 CARTON (80425-0258-1) / 9 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 17, 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): Sumatriptan
Generic name (nonproprietary): sumatriptan
Active ingredients: Sumatriptan succinate — 100 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 078284
Marketing start: Jan 17, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0258_2a9ba8f4-6ce4-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6ce4-e827-e063-6394a90a0300SPL set ID f27ca3c0-9de0-ff9c-e053-2a95a90ab894RxCUI 313160UNII J8BDZ68989
Pharmacologic class: Serotonin-1b and Serotonin-1d Receptor Agonist

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

N480425025801 followed by a unit qualifier and the quantity

Package 80425-0258-01. 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 Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks. Sumatriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0258

What is NDC 80425-0258?: 80425-0258 is the product NDC for Sumatriptan, Sumatriptan succinate 100 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sumatriptan.
What is the active ingredient?: Sumatriptan succinate.
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 Sumatriptan?: 75 other product NDCs are listed under this name. See all Sumatriptan 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 Sumatriptan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sumatriptan	Sumatriptan succinate 6 mg/.5mL	Injection, SolutionSubcutaneous	Armas Pharmaceuticals Inc.	72485-518	72485-0518-05
Sumatriptan	Sumatriptan succinate 6 mg/.5mL	Injection, SolutionSubcutaneous	Strides Pharma Science Limited	64380-740	64380-0740-0164380-0740-02
sumatriptan	Sumatriptan succinate 6 mg/.5mL	Injection, SolutionSubcutaneous	ONESOURCE SPECIALTY PHARMA LIMITED	83270-151	83270-0151-07
sumatriptan	Sumatriptan succinate 6 mg/.5mL	Injection, SolutionSubcutaneous	ONESOURCE SPECIALTY PHARMA LIMITED	83270-152	83270-0152-07
sumatriptan	Sumatriptan succinate 6 mg/.5mL	Injection, SolutionSubcutaneous	ONESOURCE SPECIALTY PHARMA LIMITED	83270-005	83270-0005-01
sumatriptan	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8109	50090-8109-00
sumatriptan	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-660	64980-0660-2764980-0660-3664980-0660-91
sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-661	64980-0661-2764980-0661-3664980-0661-91
sumatriptan	Sumatriptan succinate 100 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-662	64980-0662-2764980-0662-3664980-0662-91
Sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0475	80425-0475-01

All 76 Sumatriptan NDCs

Other NDCs under ANDA 078284

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

FDA NDC Directory listings under ANDA 078284
Product	Strength	Form · route	Labeler	Product NDC
Sumatriptan	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7436
Sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3525
Sumatriptan	Sumatriptan succinate 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8535
Sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8619
Sumatriptan	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-344
Sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-345
Sumatriptan	Sumatriptan succinate 100 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-346
Sumatriptan	Sumatriptan succinate 100 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-404
Sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0475
Sumatriptan	Sumatriptan succinate 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-169
Sumatriptan Succinate	Sumatriptan succinate 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-596