What is NDC 80425-0304?

80425-0304 is the product NDC for Sildenafil Citrate, Sildenafil citrate 20 mg/1 tablet, 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 Sildenafil Citrate?

70 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sildenafil Citrate NDC 80425-0304 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0304Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0304Add 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
80425-0304-1	8042503040180425030401	30 TABLET in 1 BOTTLE (80425-0304-1)Marketed from Apr 12, 2023
80425-0304-2	8042503040280425030402	60 TABLET in 1 BOTTLE (80425-0304-2)Marketed from Apr 12, 2023
80425-0304-3	8042503040380425030403	90 TABLET in 1 BOTTLE (80425-0304-3)Marketed from Apr 12, 2023
80425-0304-4	8042503040480425030404	50 TABLET in 1 BOTTLE (80425-0304-4)Marketed from Jul 10, 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): Sildenafil Citrate
Generic name (nonproprietary): sildenafil citrate
Active ingredients: Sildenafil citrate — 20 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 091479
Marketing start: Apr 12, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 80425-0304_1cea7dc1-3b83-0c92-e063-6394a90aec21SPL ID 1cea7dc1-3b83-0c92-e063-6394a90aec21SPL set ID f925abbe-4977-00b0-e053-6294a90a6e53RxCUI 577033UNII BW9B0ZE037
Pharmacologic class: Phosphodiesterase 5 Inhibitor

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

N480425030401 followed by a unit qualifier and the quantity

Package 80425-0304-01. 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 Jul 10, 2024.

Indications (excerpt from the label)

1. Indications and Usage Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0304

What is NDC 80425-0304?: 80425-0304 is the product NDC for Sildenafil Citrate, Sildenafil citrate 20 mg/1 tablet, 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?: Sildenafil Citrate.
What is the active ingredient?: Sildenafil citrate.
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 Sildenafil Citrate?: 70 other product NDCs are listed under this name. See all Sildenafil Citrate 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 Sildenafil Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sildenafil Citratesildenafil	Sildenafil citrate 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4111	68788-4111-0168788-4111-0368788-4111-07
Sildenafil Citrate	Sildenafil citrate 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	53401-046	53401-0046-52
Sildenafil Citrate	Sildenafil citrate 25 mg/1	TabletOral	Northstar Rx LLC	72603-883	72603-0883-01
Sildenafil Citrate	Sildenafil citrate 50 mg/1	TabletOral	Northstar Rx LLC	72603-884	72603-0884-01
Sildenafil Citrate	Sildenafil citrate 100 mg/1	TabletOral	Northstar Rx LLC	72603-885	72603-0885-0172603-0885-02
Sildenafil Citrate	Sildenafil citrate 50 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-002	60290-0002-0160290-0002-0260290-0002-03+1 more
Sildenafil Citrate	Sildenafil citrate 100 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-003	60290-0003-0160290-0003-0260290-0003-03+2 more
Sildenafil Citrate	Sildenafil citrate 25 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-079	60290-0079-0160290-0079-0260290-0079-03+1 more
Sildenafil Citratesildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-094	82868-0094-30
Sildenafil Citrate	Sildenafil citrate 100 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0503	80425-0503-0180425-0503-0280425-0503-03

All 71 Sildenafil Citrate NDCs

Other NDCs under ANDA 091479

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

FDA NDC Directory listings under ANDA 091479
Product	Strength	Form · route	Labeler	Product NDC
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6671
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Torrent Pharmaceuticals Limited	13668-185
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-4307
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3954
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2657
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-243
Sildenafil Citrate	Sildenafil citrate 20 mg/1	TabletOral	A-S Medication Solutions	50090-3905
Sildenafil Citrate	Sildenafil citrate 20 mg/1	TabletOral	Asclemed USA, Inc.	76420-613