What is NDC 0480-9277?

0480-9277 is the product NDC for Alyq (tadalafil), Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alyq?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alyq NDC 0480-9277 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-9277Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-9277Add 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
0480-9277-06	00480927706	60 TABLET, FILM COATED in 1 BOTTLE (0480-9277-06)Marketed from Feb 20, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Alyq
Generic name (nonproprietary): tadalafil
Active ingredients: Tadalafil — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216932
Marketing start: Feb 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 0480-9277_cf31567c-b0e4-4d63-a357-25703ccf54eeSPL ID cf31567c-b0e4-4d63-a357-25703ccf54eeSPL set ID 2faa7a55-3054-456b-8465-6ea6dc1c0aa9RxCUI 2110455, 2123194UNII 742SXX0ICTUPC 0304809277060
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

N400480927706 followed by a unit qualifier and the quantity

Package 00480-9277-06. 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 Apr 1, 2023.

Indications (excerpt from the label)

ALYQ ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II - III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension ALYQ ® (tadalafil tablets, USP) is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II - III symptoms and etiologies …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-9277

What is NDC 0480-9277?: 0480-9277 is the product NDC for Alyq (tadalafil), Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alyq (Tadalafil).
What is the active ingredient?: Tadalafil.
Who is the labeler?: Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alyq?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Alyq (Tadalafil) NDC 0480-9277