Prescription drug · ANDA
Vardenafil Hydrochloride NDC 46708-237
Vardenafil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-237-30 | 46708023730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-237-30)Marketed from Aug 5, 2020 | |
| 46708-237-31 | 46708023731 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-237-31)Marketed from Aug 5, 2020 |
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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214031
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-237_f87ba545-36e3-4d7d-aa52-3976a44e1719SPL ID f87ba545-36e3-4d7d-aa52-3976a44e1719SPL set ID 9b8da728-8f52-4c1f-9f0c-4bd9736e912fRxCUI 349478, 349479, 349480, 402273UNII 5M8S2CU0TSUPC 0346708236304, 0346708238308, 0346708239305, 0346708237301
- 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
N446708023730followed by a unit qualifier and the quantityPackage 46708-0237-30. 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 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 46708-237
- What is NDC 46708-237?
- 46708-237 is the product NDC for Vardenafil Hydrochloride, Vardenafil hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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 |
| Vardenafil Hydrochloride | Vardenafil 2.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-151 | 33342-0151-0733342-0151-1133342-0151-12 |
Other NDCs under ANDA 214031
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 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-236 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-238 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-239 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 2.5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-236 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-237 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-238 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-239 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2357 |