What is NDC 71205-268?

71205-268 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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?

242 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tadalafil NDC 71205-268 | National Drug Code

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 NDC	11-digit (billing)	Package
71205-268-10	7120502681071205026810	10 TABLET, FILM COATED in 1 BOTTLE (71205-268-10)Marketed from Jul 1, 2019
71205-268-30	7120502683071205026830	30 TABLET, FILM COATED in 1 BOTTLE (71205-268-30)Marketed from May 1, 2019
71205-268-60	7120502686071205026860	60 TABLET, FILM COATED in 1 BOTTLE (71205-268-60)Marketed from May 1, 2019
71205-268-90	7120502689071205026890	90 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
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209167
Marketing start: Mar 27, 2019
Listing expires: Dec 31, 2027
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 Apr 1, 2022.

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)

About NDC 71205-268

What is NDC 71205-268?: 71205-268 is the product NDC for Tadalafil, Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, 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?: Proficient Rx LP, NDC labeler code 71205. 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?: 242 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-781	72603-0781-01
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-782	72603-0782-01
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-783	72603-0783-01
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NorthStar Rx, LLC	72603-784	72603-0784-01
Tadalafil	Tadalafil 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4605	70518-4605-00
tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4083	68788-4083-0168788-4083-0368788-4083-07
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8039	50090-8039-0050090-8039-0150090-8039-02
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-027	60290-0027-0160290-0027-0260290-0027-03+1 more
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-028	60290-0028-0160290-0028-0260290-0028-03+1 more
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Umedica Laboratories USA Inc.	60290-029	60290-0029-0160290-0029-0260290-0029-03+1 more

All 243 Tadalafil NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-369
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-370
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-371
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-372
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6150
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-473
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-487
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-8409
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2553
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5186
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5202
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8153
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-269
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-502
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-720
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1587
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1620
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-126