Prescription drug · ANDA
Vardenafil Hydrochloride NDC 0093-7652
Vardenafil hydrochloride 2.5 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7652-56 | 00093765256 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7652-56)Marketed from Jan 3, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091347
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-7652_51f4534a-5b11-490a-9e0b-ac681150967fSPL ID 51f4534a-5b11-490a-9e0b-ac681150967fSPL set ID e593ab58-70a4-4095-8091-16a4b6d49e4dRxCUI 349478, 349479, 349480, 402273UNII 5M8S2CU0TSUPC 0300937654568, 0300937653561
- 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
N400093765256followed by a unit qualifier and the quantityPackage 00093-7652-56. 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.
Other NDCs under ANDA 091347
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 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7654 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7653 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7655 |
| Vardenafil Hydrochloride | Vardenafil hydrochloride 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9688 |