NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2553Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2553Add 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
68071-2553-36807125530330 TABLET, FILM COATED in 1 BOTTLE (68071-2553-3)Marketed from Oct 25, 2021

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)
Tadalafil
Generic name (nonproprietary)
tadalafil
Active ingredients
Tadalafil — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209167
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 68071-2553_2dcc51e1-75df-27c3-e063-6394a90aac6fSPL ID 2dcc51e1-75df-27c3-e063-6394a90aac6fSPL set ID cf35291b-b05b-1182-e053-2995a90a8deeRxCUI 402019UNII 742SXX0ICTUPC 0368071255331
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

N468071255303 followed by a unit qualifier and the quantity

Package 68071-2553-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 209167

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

FDA NDC Directory listings under ANDA 209167
ProductStrengthForm · routeLabelerProduct NDC
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8409
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-473
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-487
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8153
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-370
TadalafilTadalafil 2.5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-369
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-371
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-372
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5186
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5202
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-720
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1587
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6150
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1620
TadalafilTadalafil 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-502
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-126
TadalafilTadalafil 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-268
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-269

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