What is NDC 71610-508?

71610-508 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 20 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 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 Vardenafil Hydrochloride?

30 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vardenafil Hydrochloride NDC 71610-508

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-508Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0508Add 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
71610-508-02	71610050802	2 TABLET in 1 BOTTLE (71610-508-02)Marketed from Dec 21, 2020
71610-508-04	71610050804	4 TABLET in 1 BOTTLE (71610-508-04)Marketed from Dec 21, 2020
71610-508-12	71610050812	12 TABLET in 1 BOTTLE (71610-508-12)Marketed from Dec 21, 2020

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 Hydrochloride
Generic name (nonproprietary): vardenafil hydrochloride
Active ingredients: Vardenafil hydrochloride — 20 mg/1
Dosage form: Tablet
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 209057
Marketing start: Nov 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 71610-508_56a14d26-0c09-4a32-bec0-d4fba1003548SPL ID 56a14d26-0c09-4a32-bec0-d4fba1003548SPL set ID 09366eb3-93e0-41d9-bf9a-24335ed3555fRxCUI 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

N471610050802 followed by a unit qualifier and the quantity

Package 71610-0508-02. 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 Jan 27, 2021.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-508

What is NDC 71610-508?: 71610-508 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 20 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vardenafil Hydrochloride.
What is the active ingredient?: Vardenafil hydrochloride.
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 Hydrochloride?: 30 other product NDCs are listed under this name. See all Vardenafil Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Vardenafil Hydrochloride	Vardenafil hydrochloride 5 mg/1	TabletOral	AvKARE	42291-826	42291-0826-30
Vardenafil Hydrochloride	Vardenafil hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-236	46708-0236-3046708-0236-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-237	46708-0237-3046708-0237-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-238	46708-0238-3046708-0238-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-239	46708-0239-3046708-0239-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-236	62332-0236-3062332-0236-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-237	62332-0237-3062332-0237-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-238	62332-0238-3062332-0238-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-239	62332-0239-3062332-0239-31
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2357	71335-2357-01

All 31 Vardenafil Hydrochloride NDCs

Other NDCs under ANDA 209057

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

FDA NDC Directory listings under ANDA 209057
Product	Strength	Form · route	Labeler	Product NDC
Vardenafil Hydrochloride	Vardenafil hydrochloride 2.5 mg/1	TabletOral	Chartwell RX, LLC	62135-864
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-9689
Vardenafil Hydrochloride	Vardenafil hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-9696
Vardenafil Hydrochloride	Vardenafil hydrochloride 2.5 mg/1	TabletOral	Lannett Company, Inc.	0527-2800
Vardenafil Hydrochloride	Vardenafil hydrochloride 5 mg/1	TabletOral	Lannett Company, Inc.	0527-2801
Vardenafil Hydrochloride	Vardenafil hydrochloride 10 mg/1	TabletOral	Lannett Company, Inc.	0527-2802
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	TabletOral	Lannett Company, Inc.	0527-2803
Vardenafil Hydrochloride	Vardenafil hydrochloride 5 mg/1	TabletOral	AvKARE	42291-826
Vardenafil Hydrochloride	Vardenafil hydrochloride 10 mg/1	TabletOral	AvKARE	42291-847
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	TabletOral	AvKARE	42291-848
Vardenafil Hydrochloride	Vardenafil hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2235
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-2236