Prescription drug · ANDA
Sildenafil Citrate (Sildenafil) NDC 82009-093
Sildenafil citrate 100 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-093-01 | 8200900930182009009301 | 100 TABLET, FILM COATED in 1 BOTTLE (82009-093-01)Marketed from Jul 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 Citrate
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Quallent Pharmaceuticals Health LLCNDC labeler code 82009
- 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 82009-093_853230e4-4f33-420e-bd3c-d5b45f4e0689SPL ID 853230e4-4f33-420e-bd3c-d5b45f4e0689SPL set ID 41b67fd2-3d9a-49d6-88b8-285044b98dc1RxCUI 314229UNII BW9B0ZE037UPC 0382009093017
- 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
N482009009301followed by a unit qualifier and the quantityPackage 82009-0093-01. 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 82009-093
- What is NDC 82009-093?
- 82009-093 is the product NDC for Sildenafil Citrate (sildenafil), Sildenafil citrate 100 mg/1 tablet, film coated, listed with the FDA by Quallent Pharmaceuticals Health LLC. 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?
- Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3549 |
| 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 | Proficient Rx LP | 82804-025 |