Prescription drug · ANDA
Vardenafil Hydrochloride NDC 33342-151
Vardenafil 2.5 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-151-07 | 33342015107 | 30 TABLET in 1 BOTTLE (33342-151-07)Marketed from Oct 24, 2019 | |
| 33342-151-11 | 33342015111 | 100 TABLET in 1 BOTTLE (33342-151-11)Marketed from Oct 24, 2019 | |
| 33342-151-12 | 33342015112 | 10 BLISTER PACK in 1 CARTON (33342-151-12) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 24, 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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204632
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-151_b02d220c-5dd4-4557-880a-7d4c0d8927b9SPL ID b02d220c-5dd4-4557-880a-7d4c0d8927b9SPL set ID a38de6e1-21ca-4ebe-a3c7-6f849cf8b675RxCUI 349478, 349479, 349480, 402273UNII UCE6F4125HUPC 0333342154071, 0068100003338
- 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
N433342015107followed by a unit qualifier and the quantityPackage 33342-0151-07. 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. V ardenafil 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 33342-151
- What is NDC 33342-151?
- 33342-151 is the product NDC for Vardenafil Hydrochloride, Vardenafil 2.5 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 204632
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 5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-152 |
| Vardenafil Hydrochloride | Vardenafil 10 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-153 |
| Vardenafil Hydrochloride | Vardenafil 20 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-154 |