Tadliq (tadalafil) NDC 46287-045

NDC codes

FDA NDC Directory

Product NDC (as listed)46287-045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46287-0045Add 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
46287-045-15	46287004515	150 mL in 1 BOTTLE (46287-045-15)Marketed from Aug 30, 2022

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): Tadliq
Generic name (nonproprietary): tadalafil
Active ingredients: Tadalafil — 20 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: CMP Pharma, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214522
Marketing start: Aug 30, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 46287-045_cf6ec62b-5d5e-49ed-8d46-8a759d0e2b93SPL ID cf6ec62b-5d5e-49ed-8d46-8a759d0e2b93SPL set ID 7a909b25-3772-403e-a5fe-e4a040293fb7RxCUI 2613563, 2613569UNII 742SXX0ICT
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

N446287004515 followed by a unit qualifier and the quantity

Package 46287-0045-15. 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 Oct 15, 2022.

Indications (excerpt from the label)

TADLIQ 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 TADLIQ ® 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 of idiopathic or herita…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)