What is NDC 42291-826?

42291-826 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 5 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-826

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-826Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0826Add 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	Copy
42291-826-30	42291082630	30 TABLET in 1 BOTTLE (42291-826-30)Marketed from Jul 28, 2025

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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209057
Marketing start: Jul 28, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 42291-826_3b038d71-adaa-fc9a-e063-6294a90abe6aSPL ID 3b038d71-adaa-fc9a-e063-6294a90abe6aSPL set ID 3b03952b-d404-09cd-e063-6294a90a8b2cRxCUI 349478UNII 5M8S2CU0TSUPC 0342291847309
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

N442291082630 followed by a unit qualifier and the quantity

Package 42291-0826-30. 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 Jul 28, 2025.

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 42291-826

What is NDC 42291-826?: 42291-826 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 5 mg/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, 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?: AvKARE, NDC labeler code 42291. 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 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
Vardenafil Hydrochloride	Vardenafil 2.5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-151	33342-0151-0733342-0151-1133342-0151-12

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 10 mg/1	TabletOral	AvKARE	42291-847
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	TabletOral	AvKARE	42291-848
Vardenafil Hydrochloride	Vardenafil hydrochloride 20 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-508
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