What is NDC 69543-419?

69543-419 is the product NDC for sildenafil, Sildenafil citrate 10 mg/mL for suspension, listed with the FDA by Virtus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Virtus Pharmaceuticals, LLC, NDC labeler code 69543. 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?

150 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

sildenafil NDC 69543-419 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69543-419Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69543-0419Add 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
69543-419-72	6954304197269543041972	1 BOTTLE in 1 CARTON (69543-419-72) / 112 mL in 1 BOTTLEMarketed from Aug 2, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary): sildenafil
Active ingredients: Sildenafil citrate — 10 mg/mL
Dosage form: For suspension
Route: Oral
Labeler: Virtus Pharmaceuticals, LLCNDC labeler code 69543
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213814
Marketing start: Aug 2, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 69543-419_02b1c256-2d9e-4dc2-a034-ea50d1699bf9SPL ID 02b1c256-2d9e-4dc2-a034-ea50d1699bf9SPL set ID 8526e8f2-4bb4-430b-9e38-68ee68caa5a4RxCUI 1307427UNII 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

N469543041972 followed by a unit qualifier and the quantity

Package 69543-0419-72. 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 Jan 30, 2024.

Indications (excerpt from the label)

Adults Sildenafil for Oral Suspension is 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 use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise abil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69543-419

What is NDC 69543-419?: 69543-419 is the product NDC for sildenafil, Sildenafil citrate 10 mg/mL for suspension, listed with the FDA by Virtus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: sildenafil.
What is the active ingredient?: Sildenafil citrate.
Who is the labeler?: Virtus Pharmaceuticals, LLC, NDC labeler code 69543. 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?: 150 other product NDCs are listed under this name. See all sildenafil 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sildenafil	Sildenafil citrate 25 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-434	59746-0434-0359746-0434-0459746-0434-05+2 more
Sildenafil	Sildenafil citrate 50 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-435	59746-0435-0159746-0435-0359746-0435-04+3 more
Sildenafil	Sildenafil citrate 100 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-436	59746-0436-0159746-0436-0359746-0436-04+3 more
Sildenafil	Sildenafil citrate 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4596	70518-4596-00
Sildenafilsildenafil citrate	Sildenafil citrate 25 mg/1	FilmOral	Yaral Pharma Inc.	82347-0205	82347-0205-0482347-0205-0582347-0205-06
Sildenafilsildenafil citrate	Sildenafil citrate 50 mg/1	FilmOral	Yaral Pharma Inc.	82347-0210	82347-0210-0482347-0210-0582347-0210-06
Sildenafilsildenafil citrate	Sildenafil citrate 75 mg/1	FilmOral	Yaral Pharma Inc.	82347-0215	82347-0215-0482347-0215-0582347-0215-06
Sildenafilsildenafil citrate	Sildenafil citrate 100 mg/1	FilmOral	Yaral Pharma Inc.	82347-0220	82347-0220-0482347-0220-0582347-0220-06
Sildenafil	Sildenafil citrate 20 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-987	51407-0987-90
Sildenafil	Sildenafil citrate 20 mg/1	TabletOral	AvKARE	42291-937	42291-0937-90

All 151 sildenafil NDCs