Prescription drug · ANDA
Vardenafil Hydrochloride NDC 42291-847
Vardenafil hydrochloride 10 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-847-30 | 42291084730 | 30 TABLET in 1 BOTTLE (42291-847-30)Marketed from Jan 31, 2019 |
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)
- Vardenafil Hydrochloride
- Generic name (nonproprietary)
- vardenafil hydrochloride
- Active ingredients
- Vardenafil hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- 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 42291-847_4875c23d-91ea-f449-e063-6394a90a5a74SPL ID 4875c23d-91ea-f449-e063-6394a90a5a74SPL set ID 80c4793d-e19e-10f0-e053-2991aa0a4620RxCUI 349479, 349480UNII 5M8S2CU0TSUPC 0342291847309, 0342291848306
- 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
N442291084730followed by a unit qualifier and the quantityPackage 42291-0847-30. 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.
About NDC 42291-847
- What is NDC 42291-847?
- 42291-847 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 10 mg/1 tablet, listed with the FDA by AvKARE. 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?
- AvKARE, NDC labeler code 42291. 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.
Related NDCs: other Vardenafil Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | TabletOral | AvKARE | 42291-826 | 42291-0826-30 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-236 | 46708-0236-3046708-0236-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-237 | 46708-0237-3046708-0237-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-238 | 46708-0238-3046708-0238-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-239 | 46708-0239-3046708-0239-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-236 | 62332-0236-3062332-0236-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-237 | 62332-0237-3062332-0237-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-238 | 62332-0238-3062332-0238-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-239 | 62332-0239-3062332-0239-31 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2357 | 71335-2357-01 |
Other NDCs under ANDA 209057
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 |
|---|---|---|---|---|
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-864 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9689 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9696 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2800 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2801 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2802 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Lannett Company, Inc. | 0527-2803 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | TabletOral | AvKARE | 42291-826 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | AvKARE | 42291-848 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-508 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2235 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2236 |