What is NDC 71610-477?

71610-477 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 20 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Vardenafil hydrochloride trihydrate.

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 Vardenafil?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vardenafil NDC 71610-477 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-477Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0477Add 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
71610-477-02	7161004770271610047702	2 TABLET, FILM COATED in 1 BOTTLE (71610-477-02)Marketed from Nov 5, 2020
71610-477-04	7161004770471610047704	4 TABLET, FILM COATED in 1 BOTTLE (71610-477-04)Marketed from Oct 23, 2020
71610-477-06	7161004770671610047706	6 TABLET, FILM COATED in 1 BOTTLE (71610-477-06)Marketed from May 3, 2021
71610-477-12	7161004771271610047712	12 TABLET, FILM COATED in 1 BOTTLE (71610-477-12)Marketed from Apr 7, 2021

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): Vardenafil
Generic name (nonproprietary): vardenafil
Active ingredients: Vardenafil hydrochloride trihydrate — 20 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 208960
Marketing start: Nov 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 71610-477_9d2796f2-b596-4588-96c8-f99407d3e671SPL ID 9d2796f2-b596-4588-96c8-f99407d3e671SPL set ID c70a9c8e-46b0-489d-bbda-2d7fca4b629fRxCUI 349480UNII 5M8S2CU0TS
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

N471610047702 followed by a unit qualifier and the quantity

Package 71610-0477-02. 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 Nov 11, 2020.

Indications (excerpt from the label)

Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ) Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-477

What is NDC 71610-477?: 71610-477 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 20 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vardenafil.
What is the active ingredient?: Vardenafil hydrochloride trihydrate.
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 Vardenafil?: 11 other product NDCs are listed under this name. See all Vardenafil 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 Vardenafil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Vardenafil	Vardenafil hydrochloride trihydrate 10 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Limited	46708-235	46708-0235-04
Vardenafil	Vardenafil hydrochloride trihydrate 10 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-235	62332-0235-04
Vardenafil	Vardenafil hydrochloride trihydrate 2.5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1068	70710-1068-0170710-1068-0370710-1068-09
Vardenafil	Vardenafil hydrochloride trihydrate 5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1069	70710-1069-0170710-1069-0370710-1069-09
Vardenafil	Vardenafil hydrochloride trihydrate 10 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1070	70710-1070-0170710-1070-0370710-1070-09
Vardenafil	Vardenafil hydrochloride trihydrate 20 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1071	70710-1071-0170710-1071-0370710-1071-09
Vardenafil	Vardenafil hydrochloride trihydrate 2.5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1047	70771-1047-0170771-1047-0370771-1047-09
Vardenafil	Vardenafil hydrochloride trihydrate 5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1048	70771-1048-0170771-1048-0370771-1048-09
Vardenafil	Vardenafil hydrochloride trihydrate 10 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1049	70771-1049-0170771-1049-0370771-1049-09
Vardenafil	Vardenafil hydrochloride trihydrate 20 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1050	70771-1050-0170771-1050-0370771-1050-09

All 12 Vardenafil NDCs

Other NDCs under ANDA 208960

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

FDA NDC Directory listings under ANDA 208960
Product	Strength	Form · route	Labeler	Product NDC
Vardenafil	Vardenafil hydrochloride trihydrate 2.5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1068
Vardenafil	Vardenafil hydrochloride trihydrate 5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1069
Vardenafil	Vardenafil hydrochloride trihydrate 10 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1070
Vardenafil	Vardenafil hydrochloride trihydrate 20 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1071
Vardenafil	Vardenafil hydrochloride trihydrate 2.5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1047
Vardenafil	Vardenafil hydrochloride trihydrate 5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1048
Vardenafil	Vardenafil hydrochloride trihydrate 10 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1049
Vardenafil	Vardenafil hydrochloride trihydrate 20 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1050