Prescription drug · ANDA
Sildenafil NDC 68001-597
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-597-05 | 6800105970568001059705 | 90 TABLET, FILM COATED in 1 BOTTLE (68001-597-05)Marketed from Jun 12, 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203814
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68001-597_5cd18d2f-369d-1fbd-e063-6394a90af069SPL ID 5cd18d2f-369d-1fbd-e063-6394a90af069
- 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
N468001059705followed by a unit qualifier and the quantityPackage 68001-0597-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68001-597
- What is NDC 68001-597?
- 68001-597 is the product NDC for Sildenafil, Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, 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?
- BluePoint Laboratories, NDC labeler code 68001. 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 203814
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 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5115 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4517 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1005 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-2072 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-813 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-061 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-121 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-788 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-363 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-536 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1638 |