What is NDC 71610-581?

71610-581 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-581 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0581Add 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
71610-581-04	7161005810471610058104	4 TABLET, FILM COATED in 1 BOTTLE (71610-581-04)Marketed from Jul 12, 2021
71610-581-06	7161005810671610058106	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-06)Marketed from Feb 1, 2023
71610-581-12	7161005811271610058112	12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12)Marketed from Jul 12, 2021
71610-581-39	7161005813971610058139	1440 TABLET, FILM COATED in 1 BOTTLE (71610-581-39)Marketed from Apr 3, 2024
71610-581-52	7161005815271610058152	18 TABLET, FILM COATED in 1 BOTTLE (71610-581-52)Marketed from Sep 5, 2024

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209744
Marketing start: Jan 21, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 71610-581_21f23cde-ebd8-aa67-e063-6394a90a7150SPL ID 21f23cde-ebd8-aa67-e063-6394a90a7150SPL set ID f2e8821e-04c9-4812-8c9e-39340775cc6eRxCUI 484814UNII 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

N471610058104 followed by a unit qualifier and the quantity

Package 71610-0581-04. 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 Sep 12, 2024.

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 is 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 tablets are indicated f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-581

What is NDC 71610-581?: 71610-581 is the product NDC for Tadalafil, Tadalafil 10 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 209744

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

FDA NDC Directory listings under ANDA 209744
Product	Strength	Form · route	Labeler	Product NDC
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	AvKARE	42291-864
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	AvKARE	42291-865
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	AvKARE	42291-866
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	AvKARE	42291-867
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1346
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1347
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1348
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1349
Tadalafil	Tadalafil 2.5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1346
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1347
Tadalafil	Tadalafil 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1348
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1349
Tadalafil	Tadalafil 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-567
Tadalafil	Tadalafil 5 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-603