NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1049Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1049Add 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 NDC11-digit (billing)PackageCopy
70771-1049-17077110490170771104901100 TABLET, FILM COATED in 1 BOTTLE (70771-1049-1)Marketed from Nov 1, 2018
70771-1049-3707711049037077110490330 TABLET, FILM COATED in 1 BOTTLE (70771-1049-3)Marketed from Nov 1, 2018
70771-1049-9707711049097077110490990 TABLET, FILM COATED in 1 BOTTLE (70771-1049-9)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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208960
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 70771-1049_4fb9ca6c-4610-42f9-87f0-224d76c542f2SPL ID 4fb9ca6c-4610-42f9-87f0-224d76c542f2SPL set ID 8ea14f7e-44a0-4d9c-968a-87b97ca12f09RxCUI 349478, 349479, 349480, 402273UNII 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

N470771104901 followed by a unit qualifier and the quantity

Package 70771-1049-01. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1049

What is NDC 70771-1049?
70771-1049 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 10 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 70771. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
VardenafilVardenafil hydrochloride trihydrate 10 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Limited46708-23546708-0235-04
VardenafilVardenafil hydrochloride trihydrate 10 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-23562332-0235-04
VardenafilVardenafil hydrochloride trihydrate 2.5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-106870710-1068-0170710-1068-0370710-1068-09
VardenafilVardenafil hydrochloride trihydrate 5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-106970710-1069-0170710-1069-0370710-1069-09
VardenafilVardenafil hydrochloride trihydrate 10 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-107070710-1070-0170710-1070-0370710-1070-09
VardenafilVardenafil hydrochloride trihydrate 20 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-107170710-1071-0170710-1071-0370710-1071-09
VardenafilVardenafil hydrochloride trihydrate 2.5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-104770771-1047-0170771-1047-0370771-1047-09
VardenafilVardenafil hydrochloride trihydrate 5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-104870771-1048-0170771-1048-0370771-1048-09
VardenafilVardenafil hydrochloride trihydrate 20 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-105070771-1050-0170771-1050-0370771-1050-09
VardenafilVardenafil hydrochloride trihydrate 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-47771610-0477-0271610-0477-0471610-0477-06+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
ProductStrengthForm · routeLabelerProduct NDC
VardenafilVardenafil hydrochloride trihydrate 2.5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-1068
VardenafilVardenafil hydrochloride trihydrate 5 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-1069
VardenafilVardenafil hydrochloride trihydrate 10 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-1070
VardenafilVardenafil hydrochloride trihydrate 20 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-1071
VardenafilVardenafil hydrochloride trihydrate 2.5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1047
VardenafilVardenafil hydrochloride trihydrate 5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1048
VardenafilVardenafil hydrochloride trihydrate 20 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1050
VardenafilVardenafil hydrochloride trihydrate 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-477

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