Sildenafil NDC 69238-1574

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1574Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1574Add 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
69238-1574-1	69238157401	1 BOTTLE, GLASS in 1 CARTON (69238-1574-1) / 112 mL in 1 BOTTLE, GLASSMarketed from Dec 6, 2019

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
Generic name (nonproprietary): sildenafil
Active ingredients: Sildenafil — 10 mg/mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211092
Marketing start: Dec 6, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86ebSPL ID 87224b5f-b3ee-40e4-8ac1-45356a1b86ebSPL set ID 9de84092-ebe6-436c-a925-88a6e3861ebaRxCUI 1307427UNII 3M7OB98Y7H
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

N469238157401 followed by a unit qualifier and the quantity

Package 69238-1574-01. 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 Nov 26, 2023.

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) oral suspension. 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 exerci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211092

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

FDA NDC Directory listings under ANDA 211092
Product	Strength	Form · route	Labeler	Product NDC
Sildenafil	Sildenafil 10 mg/mL	Powder, For suspensionOral	Amneal Pharmaceuticals NY LLC	60219-2651