Prescription drug · ANDA
Sildenafil NDC 68071-2072
Sildenafil citrate 20 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2072-1 | 68071207201 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-2072-1)Marketed from Jan 24, 2017 | |
| 68071-2072-2 | 68071207202 | 28 TABLET, FILM COATED in 1 BOTTLE (68071-2072-2)Marketed from Jan 24, 2017 | |
| 68071-2072-4 | 68071207204 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-2072-4)Marketed from Jan 24, 2017 | |
| 68071-2072-5 | 68071207205 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2072-5)Marketed from Jan 24, 2017 |
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
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203814
- Marketing start
- Marketing end
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2072_1d609fda-9b9d-40b3-e063-6294a90a63b9SPL ID 1d609fda-9b9d-40b3-e063-6294a90a63b9SPL set ID 46dff4c0-9a6c-20f9-e054-00144ff8d46cRxCUI 577033UNII BW9B0ZE037UPC 0368071207248
- 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
N468071207201followed by a unit qualifier and the quantityPackage 68071-2072-01. 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 tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [ see Clinical Studies (14) ]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203814
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 | American Health Packaging | 60687-788 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5115 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4517 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-121 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1005 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-536 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-597 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-061 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-813 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1638 |
| Sildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-363 |