NDC codes

FDA NDC Directory
Product NDC (as listed)71205-268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0268Add 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
71205-268-107120502681010 TABLET, FILM COATED in 1 BOTTLE (71205-268-10)Marketed from Jul 1, 2019
71205-268-307120502683030 TABLET, FILM COATED in 1 BOTTLE (71205-268-30)Marketed from May 1, 2019
71205-268-607120502686060 TABLET, FILM COATED in 1 BOTTLE (71205-268-60)Marketed from May 1, 2019
71205-268-907120502689090 TABLET, FILM COATED in 1 BOTTLE (71205-268-90)Marketed from May 1, 2019

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, 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 71205-268_cfe4f78a-2bff-4f77-a582-f9027a8eb62eSPL ID cfe4f78a-2bff-4f77-a582-f9027a8eb62eSPL set ID 6fa9d4fa-86c9-4791-b28b-78e8b9341ceaRxCUI 402019UNII 742SXX0ICTUPC 0371205268107
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

N471205026810 followed by a unit qualifier and the quantity

Package 71205-0268-10. 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: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2553
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-126
TadalafilTadalafil 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-269

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in