Prescription drug · ANDA
Sildenafil Citrate (Sildenafil) NDC 70518-1641
Sildenafil citrate 50 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70518-1641Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-1641Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1641-0 | 7051816410070518164100 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1641-0)Marketed from Nov 7, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Citrate
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091448
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-1641_5d16eca9-0fd9-d71a-e063-6294a90ae2ceSPL ID 5d16eca9-0fd9-d71a-e063-6294a90ae2ce
- 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
N470518164100followed by a unit qualifier and the quantityPackage 70518-1641-00. 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 70518-1641
- What is NDC 70518-1641?
- 70518-1641 is the product NDC for Sildenafil Citrate (sildenafil), Sildenafil citrate 50 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sildenafil Citrate (Sildenafil).
- What is the active ingredient?
- Sildenafil citrate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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 Citrate?
- 70 other product NDCs are listed under this name. See all Sildenafil Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sildenafil Citrate 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 Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4111 | 68788-4111-0168788-4111-0368788-4111-07 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-046 | 53401-0046-52 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | TabletOral | Northstar Rx LLC | 72603-883 | 72603-0883-01 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | Northstar Rx LLC | 72603-884 | 72603-0884-01 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Northstar Rx LLC | 72603-885 | 72603-0885-0172603-0885-02 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-002 | 60290-0002-0160290-0002-0260290-0002-03+1 more |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-003 | 60290-0003-0160290-0003-0260290-0003-03+2 more |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-079 | 60290-0079-0160290-0079-0260290-0079-03+1 more |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-094 | 82868-0094-30 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0503 | 80425-0503-0180425-0503-0280425-0503-03 |
Other NDCs under ANDA 091448
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 Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-231 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3049 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3111 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3862 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2241 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-186 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-187 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-188 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4111 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-794 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-940 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-941 |