Prescription drug · ANDA
Sildenafil NDC 35561-253
Sildenafil citrate 100 mg/1 · Tablet, Film coated · Oral · Bostal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35561-253-10 | 3556102531035561025310 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-253-10)Marketed from Apr 22, 2020 | |
| 35561-253-14 | 3556102531435561025314 | 1000 TABLET, FILM COATED in 1 BOTTLE (35561-253-14)Marketed from Apr 22, 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)
- Sildenafil
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bostal LLCNDC labeler code 35561
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208494
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 35561-253_49fc9324-58cc-2875-e063-6394a90a5363SPL ID 49fc9324-58cc-2875-e063-6394a90a5363SPL set ID 428bbcff-0faf-499c-81b2-6ac76c0687c0RxCUI 312950, 314228, 314229UNII BW9B0ZE037UPC 0335561253146, 0335561252149, 0335561251142
- 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
N435561025310followed by a unit qualifier and the quantityPackage 35561-0253-10. 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 is indicated for the treatment of erectile dysfunction. SILDENAFIL TABLETS is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)
Excerpt only. Read the full label for complete information.
About NDC 35561-253
- What is NDC 35561-253?
- 35561-253 is the product NDC for Sildenafil, Sildenafil citrate 100 mg/1 tablet, film coated, listed with the FDA by Bostal LLC. It has 2 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?
- Bostal LLC, NDC labeler code 35561. 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 208494
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 25 mg/1 | Tablet, Film coatedOral | Bostal LLC | 35561-251 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Bostal LLC | 35561-252 |
| Sildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Reyoung Corporation | 82647-210 |
| Sildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Reyoung Corporation | 82647-211 |
| Sildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Reyoung Corporation | 82647-212 |