NDC codes

FDA NDC Directory
Product NDC (as listed)27241-123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0123Add 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 NDC11-digit (billing)PackageCopy
27241-123-022724101230260 TABLET in 1 BOTTLE (27241-123-02)Marketed from Jul 4, 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)
Tadalafil
Generic name (nonproprietary)
tadalafil
Active ingredients
Tadalafil — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Ajanta Pharma USA Inc.NDC labeler code 27241
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210392
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 27241-123_e21837f2-58d2-4fb1-87b3-f751b94312a9SPL ID e21837f2-58d2-4fb1-87b3-f751b94312a9SPL set ID fceb8aaf-b4eb-4004-8ca4-f004eac6b314RxCUI 2123194UNII 742SXX0ICTUPC 0327241123023
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

N427241012302 followed by a unit qualifier and the quantity

Package 27241-0123-02. 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 .

Indications (excerpt from the label)

Tadalafil 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 Tadalafil Tablets are 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 idiopat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27241-123

What is NDC 27241-123?
27241-123 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, listed with the FDA by Ajanta Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tadalafil.
What is the active ingredient?
Tadalafil.
Who is the labeler?
Ajanta Pharma USA Inc., NDC labeler code 27241. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tadalafil?
241 other product NDCs are listed under this name. See all Tadalafil 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 Tadalafil NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78172603-0781-01
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78272603-0782-01
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78372603-0783-01
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthStar Rx, LLC72603-78472603-0784-01
TadalafilTadalafil 5 mg/1TabletOralREMEDYREPACK INC.70518-460570518-4605-00
tadalafilTadalafil 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-408368788-4083-0168788-4083-0368788-4083-07
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-02860290-0028-0160290-0028-0260290-0028-03+1 more
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-02960290-0029-0160290-0029-0260290-0029-03+1 more
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-03060290-0030-0160290-0030-0260290-0030-03+2 more
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.60290-02760290-0027-0160290-0027-0260290-0027-03+1 more

All 242 Tadalafil NDCs

Other NDCs under ANDA 210392

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

FDA NDC Directory listings under ANDA 210392
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 20 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-080

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