What is NDC 70710-1068?

70710-1068 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 2.5 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Vardenafil hydrochloride trihydrate.

Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 70710-1068 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-1068Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-1068Add 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
70710-1068-1	7071010680170710106801	100 TABLET, FILM COATED in 1 BOTTLE (70710-1068-1)Marketed from Nov 1, 2018
70710-1068-3	7071010680370710106803	30 TABLET, FILM COATED in 1 BOTTLE (70710-1068-3)Marketed from Nov 1, 2018
70710-1068-9	7071010680970710106809	90 TABLET, FILM COATED in 1 BOTTLE (70710-1068-9)Marketed from Nov 1, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208960
Marketing start: Nov 1, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers: Product ID 70710-1068_a6417d62-c65a-49a5-a3c7-d9d178a36cb9SPL ID a6417d62-c65a-49a5-a3c7-d9d178a36cb9SPL set ID 5876e062-e604-42a7-99c3-5da30b8dac06RxCUI 349478, 349479, 349480, 402273UNII 5M8S2CU0TSUPC 0370710106935
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

N470710106801 followed by a unit qualifier and the quantity

Package 70710-1068-01. 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 5, 2026.

Indications (excerpt from the label)

Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ) Vardenafil 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 70710-1068

What is NDC 70710-1068?: 70710-1068 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 2.5 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 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
Vardenafil	Vardenafil hydrochloride trihydrate 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-477	71610-0477-0271610-0477-0471610-0477-06+1 more

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 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
Vardenafil	Vardenafil hydrochloride trihydrate 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-477