Prescription drug · ANDA
Sildenafil NDC 71335-1649
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1649-0 | 71335164900 | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1649-0)Marketed from Mar 1, 2022 | |
| 71335-1649-1 | 71335164901 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1649-1)Marketed from Jul 9, 2020 | |
| 71335-1649-2 | 71335164902 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1649-2)Marketed from Jun 24, 2020 | |
| 71335-1649-3 | 71335164903 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1649-3)Marketed from May 10, 2021 | |
| 71335-1649-4 | 71335164904 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1649-4)Marketed from Jun 23, 2020 | |
| 71335-1649-5 | 71335164905 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1649-5)Marketed from Mar 31, 2021 | |
| 71335-1649-6 | 71335164906 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1649-6)Marketed from Aug 13, 2020 | |
| 71335-1649-7 | 71335164907 | 270 TABLET, FILM COATED in 1 BOTTLE (71335-1649-7)Marketed from May 30, 2024 | |
| 71335-1649-8 | 71335164908 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1649-8)Marketed from Jul 12, 2021 | |
| 71335-1649-9 | 71335164909 | 12 TABLET, FILM COATED in 1 BOTTLE (71335-1649-9)Marketed from May 30, 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
- Generic name (nonproprietary)
- sildenafil
- Active ingredients
- Sildenafil citrate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203623
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1649_841b6c33-e16d-4bbb-80df-3c35c73287d3SPL ID 841b6c33-e16d-4bbb-80df-3c35c73287d3SPL set ID af5277be-124b-4541-b6b2-bb55246cb8edRxCUI 577033UNII BW9B0ZE037
- 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
N471335164900followed by a unit qualifier and the quantityPackage 71335-1649-00. 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)
Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ( 14 )] . Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203623
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. | 68071-2213 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-776 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals, Inc. | 72865-105 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2363 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5236 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-619 |