Prescription drug · ANDA
Sildenafil NDC 33342-041
Sildenafil citrate 25 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-041-07 | 3334200410733342004107 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-041-07)Marketed from Apr 19, 2023 | |
| 33342-041-11 | 3334200411133342004111 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-041-11)Marketed from Apr 19, 2023 | |
| 33342-041-44 | 3334200414433342004144 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-041-44)Marketed from Apr 19, 2023 | |
| 33342-041-98 | 3334200419833342004198 | 1 BLISTER PACK in 1 CARTON (33342-041-98) / 60 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 19, 2023 |
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)
- Sildenafil
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202255
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-041_e89d523d-8d42-4bbf-be3d-2b15e7c15f4fSPL ID e89d523d-8d42-4bbf-be3d-2b15e7c15f4fSPL set ID c2b25818-99a3-474b-a04c-929df1110834RxCUI 312950, 314228, 314229UNII BW9B0ZE037UPC 0333342043443, 0333342042446
- 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
N433342004107followed by a unit qualifier and the quantityPackage 33342-0041-07. 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)
Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets are phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 33342-041
- What is NDC 33342-041?
- 33342-041 is the product NDC for Sildenafil, Sildenafil citrate 25 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sildenafil.
- What is the active ingredient?
- Sildenafil citrate.
- 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 Sildenafil?
- 150 other product NDCs are listed under this name. See all Sildenafil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sildenafil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-434 | 59746-0434-0359746-0434-0459746-0434-05+2 more |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-435 | 59746-0435-0159746-0435-0359746-0435-04+3 more |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-436 | 59746-0436-0159746-0436-0359746-0436-04+3 more |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4596 | 70518-4596-00 |
| Sildenafilsildenafil citrate | Sildenafil citrate 25 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0205 | 82347-0205-0482347-0205-0582347-0205-06 |
| Sildenafilsildenafil citrate | Sildenafil citrate 50 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0210 | 82347-0210-0482347-0210-0582347-0210-06 |
| Sildenafilsildenafil citrate | Sildenafil citrate 75 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0215 | 82347-0215-0482347-0215-0582347-0215-06 |
| Sildenafilsildenafil citrate | Sildenafil citrate 100 mg/1 | FilmOral | Yaral Pharma Inc. | 82347-0220 | 82347-0220-0482347-0220-0582347-0220-06 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-987 | 51407-0987-90 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | AvKARE | 42291-937 | 42291-0937-90 |
Other NDCs under ANDA 202255
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 |
|---|---|---|---|---|
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-042 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-043 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7977 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3978 |