What is NDC 33342-203?

33342-203 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 11.85 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Vardenafil hydrochloride trihydrate.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 33342-203 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-203Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0203Add 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
33342-203-37	33342020337	1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACKMarketed from Oct 26, 2018

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 — 11.85 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205988
Marketing start: Oct 26, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19SPL ID 695d5a7e-546f-4e86-8edc-3c32e1d3bb19SPL set ID 0ad213e0-d18a-4e67-a405-df95322eaa52RxCUI 996179UNII 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

N433342020337 followed by a unit qualifier and the quantity

Package 33342-0203-37. 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 31, 2025.

Indications (excerpt from the label)

Vardenafil orally disintegrating tablet is indicated for the treatment of erectile dysfunction.  Vardenafil is 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 33342-203

What is NDC 33342-203?: 33342-203 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 11.85 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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