Prescription drug · ANDA
Vardenafil NDC 46708-235
Vardenafil hydrochloride trihydrate 10 mg/1 · Tablet, Orally disintegrating · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-235-04 | 46708023504 | 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)Marketed from Nov 20, 2018 |
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
- Generic name (nonproprietary)
- vardenafil
- Active ingredients
- Vardenafil hydrochloride trihydrate — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208324
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803SPL ID 2ca8929b-0b62-4302-9ab4-60ad3768e803SPL set ID dce0b31b-4522-4cb4-9dba-3aea2b2bb082RxCUI 996179UNII 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
N446708023504followed by a unit qualifier and the quantityPackage 46708-0235-04. 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 orally disintegrating tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).
Excerpt only. Read the full label for complete information.
About NDC 46708-235
- What is NDC 46708-235?
- 46708-235 is the product NDC for Vardenafil, Vardenafil hydrochloride trihydrate 10 mg/1 tablet, orally disintegrating, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vardenafil.
- What is the active ingredient?
- Vardenafil hydrochloride trihydrate.
- 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?
- 11 other product NDCs are listed under this name. See all Vardenafil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vardenafil 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 | Vardenafil hydrochloride trihydrate 10 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-235 | 62332-0235-04 |
| Vardenafil | Vardenafil hydrochloride trihydrate 2.5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1068 | 70710-1068-0170710-1068-0370710-1068-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 5 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1069 | 70710-1069-0170710-1069-0370710-1069-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 10 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1070 | 70710-1070-0170710-1070-0370710-1070-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 20 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1071 | 70710-1071-0170710-1071-0370710-1071-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 2.5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1047 | 70771-1047-0170771-1047-0370771-1047-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1048 | 70771-1048-0170771-1048-0370771-1048-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1049 | 70771-1049-0170771-1049-0370771-1049-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 20 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1050 | 70771-1050-0170771-1050-0370771-1050-09 |
| Vardenafil | Vardenafil hydrochloride trihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-477 | 71610-0477-0271610-0477-0471610-0477-06+1 more |
Other NDCs under ANDA 208324
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 | Vardenafil hydrochloride trihydrate 10 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-235 |