Prescription drug · ANDA
Sildenafil Citrate (Sildenafil) NDC 52817-295
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · TruPharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-295-00 | 5281702950052817029500 | 1000 TABLET, FILM COATED in 1 BOTTLE (52817-295-00)Marketed from Aug 1, 2016 | |
| 52817-295-90 | 5281702959052817029590 | 90 TABLET, FILM COATED in 1 BOTTLE (52817-295-90)Marketed from Aug 1, 2016 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TruPharma LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204883
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 52817-295_a8abd38f-2334-34e3-e053-2a95a90acb7dSPL ID a8abd38f-2334-34e3-e053-2a95a90acb7dSPL set ID c8864c64-22ad-402b-a1e8-cfb53fa02e80RxCUI 577033UNII BW9B0ZE037UPC 0352817295002, 0352817295903
- 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
N452817029500followed by a unit qualifier and the quantityPackage 52817-0295-00. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Sildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). ( 1 ) Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1 , 14 ) Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO …
Excerpt only. Read the full label for complete information.
About NDC 52817-295
- What is NDC 52817-295?
- 52817-295 is the product NDC for Sildenafil Citrate (sildenafil), Sildenafil citrate 20 mg/1 tablet, film coated, listed with the FDA by TruPharma LLC. It has 2 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?
- TruPharma LLC, NDC labeler code 52817. 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 204883
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 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-793 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-305 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-623 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-018 |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-094 |