Prescription drug · ANDA
Sildenafil Citrate (Sildenafil) NDC 68071-3549
Sildenafil citrate 100 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68071-3549Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3549Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3549-1 | 6807135490168071354901 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-3549-1)Marketed from May 15, 2024 | |
| 68071-3549-5 | 6807135490568071354905 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3549-5)Marketed from Dec 4, 2023 | |
| 68071-3549-6 | 6807135490668071354906 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3549-6)Marketed from Dec 4, 2023 | |
| 68071-3549-9 | 6807135490968071354909 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3549-9)Marketed from Apr 9, 2024 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206401
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3549_1884bfe6-392b-09dd-e063-6394a90aad46SPL ID 1884bfe6-392b-09dd-e063-6394a90aad46SPL set ID 0bb3eb8d-05cd-b4cd-e063-6294a90a94bbRxCUI 314229UNII BW9B0ZE037UPC 0368071354959
- 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
N468071354901followed by a unit qualifier and the quantityPackage 68071-3549-01. 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 citrate is indicated for the treatment of erectile dysfunction. Sildenafil citrate 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 68071-3549
- What is NDC 68071-3549?
- 68071-3549 is the product NDC for Sildenafil Citrate (sildenafil), Sildenafil citrate 100 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 4 package NDCs, 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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 206401
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 25 mg/1 | Tablet, Film coatedOral | Ajanta Pharma USA Inc. | 27241-067 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Ajanta Pharma USA Inc. | 27241-068 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Ajanta Pharma USA Inc. | 27241-069 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5906 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3410 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3592 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3631 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3646 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3670 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8301 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1437 |
| Sildenafil Citratesildenafil | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-563 |
| Sildenafil Citratesildenafil | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-564 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-565 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0410 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-093 |
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-025 |