NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9689Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9689Add 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
71335-9689-17133596890130 TABLET in 1 BOTTLE (71335-9689-1)Marketed from Apr 6, 2023

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 Hydrochloride
Generic name (nonproprietary)
vardenafil hydrochloride
Active ingredients
Vardenafil hydrochloride — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209057
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 71335-9689_4af8686d-6590-4109-932d-45768c16aa10SPL ID 4af8686d-6590-4109-932d-45768c16aa10SPL set ID 666a622b-2464-4c55-8c90-0f1cc85bc1e9RxCUI 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

N471335968901 followed by a unit qualifier and the quantity

Package 71335-9689-01. 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 .

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 71335-9689

What is NDC 71335-9689?
71335-9689 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 20 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Vardenafil HydrochlorideVardenafil hydrochloride 5 mg/1TabletOralAvKARE42291-82642291-0826-30
Vardenafil HydrochlorideVardenafil hydrochloride 2.5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-23646708-0236-3046708-0236-31
Vardenafil HydrochlorideVardenafil hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-23746708-0237-3046708-0237-31
Vardenafil HydrochlorideVardenafil hydrochloride 10 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-23846708-0238-3046708-0238-31
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-23946708-0239-3046708-0239-31
Vardenafil HydrochlorideVardenafil hydrochloride 2.5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-23662332-0236-3062332-0236-31
Vardenafil HydrochlorideVardenafil hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-23762332-0237-3062332-0237-31
Vardenafil HydrochlorideVardenafil hydrochloride 10 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-23862332-0238-3062332-0238-31
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-23962332-0239-3062332-0239-31
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-235771335-2357-01

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
ProductStrengthForm · routeLabelerProduct NDC
Vardenafil HydrochlorideVardenafil hydrochloride 2.5 mg/1TabletOralChartwell RX, LLC62135-864
Vardenafil HydrochlorideVardenafil hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-9696
Vardenafil HydrochlorideVardenafil hydrochloride 2.5 mg/1TabletOralLannett Company, Inc.0527-2800
Vardenafil HydrochlorideVardenafil hydrochloride 5 mg/1TabletOralLannett Company, Inc.0527-2801
Vardenafil HydrochlorideVardenafil hydrochloride 10 mg/1TabletOralLannett Company, Inc.0527-2802
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1TabletOralLannett Company, Inc.0527-2803
Vardenafil HydrochlorideVardenafil hydrochloride 5 mg/1TabletOralAvKARE42291-826
Vardenafil HydrochlorideVardenafil hydrochloride 10 mg/1TabletOralAvKARE42291-847
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1TabletOralAvKARE42291-848
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-508
Vardenafil HydrochlorideVardenafil hydrochloride 10 mg/1TabletOralBryant Ranch Prepack72162-2235
Vardenafil HydrochlorideVardenafil hydrochloride 20 mg/1TabletOralBryant Ranch Prepack72162-2236

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