NDC codes

FDA NDC Directory
Product NDC (as listed)31722-442Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0442Add 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
31722-442-0131722044201100 TABLET in 1 BOTTLE (31722-442-01)Marketed from Jun 14, 2024
31722-442-303172204423030 TABLET in 1 BOTTLE (31722-442-30)Marketed from Jun 14, 2024

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)
Avanafil
Generic name (nonproprietary)
avanafil
Active ingredients
Avanafil — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209266
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 5 Inhibitors (Mechanism)
Identifiers
Product ID 31722-442_46258a47-8730-8397-e063-6394a90a6478SPL ID 46258a47-8730-8397-e063-6394a90a6478SPL set ID 1d04e17d-7399-430a-a8bb-fa1912b155e9RxCUI 1291306, 1291365, 1291369UNII DR5S136IVOUPC 0331722442305, 0331722440301, 0331722441308
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

N431722044201 followed by a unit qualifier and the quantity

Package 31722-0442-01. 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)

Avanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males. Avanafil tablet 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 31722-442

What is NDC 31722-442?
31722-442 is the product NDC for Avanafil, Avanafil 200 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Avanafil.
What is the active ingredient?
Avanafil.
Who is the labeler?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Avanafil?
2 other product NDCs are listed under this name. See all Avanafil 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 Avanafil NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AvanafilAvanafil 50 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-44031722-0440-0131722-0440-30
AvanafilAvanafil 100 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-44131722-0441-0131722-0441-30

Other NDCs under ANDA 209266

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209266
ProductStrengthForm · routeLabelerProduct NDC
AvanafilAvanafil 50 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-440
AvanafilAvanafil 100 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-441

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