Prescription drug · ANDA
Avanafil NDC 31722-442
Avanafil 200 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-442-01 | 31722044201 | 100 TABLET in 1 BOTTLE (31722-442-01)Marketed from Jun 14, 2024 | |
| 31722-442-30 | 31722044230 | 30 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
N431722044201followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Avanafil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Avanafil | Avanafil 50 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-440 | 31722-0440-0131722-0440-30 |
| Avanafil | Avanafil 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-441 | 31722-0441-0131722-0441-30 |
Other NDCs under ANDA 209266
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Avanafil | Avanafil 50 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-440 |
| Avanafil | Avanafil 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-441 |