Prescription drug · ANDA
Sildenafil NDC 68071-2602
Sildenafil citrate 20 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2602-1 | 68071260201 | 10 TABLET in 1 BOTTLE (68071-2602-1)Marketed from Jul 24, 2025 | |
| 68071-2602-3 | 68071260203 | 30 TABLET in 1 BOTTLE (68071-2602-3)Marketed from Dec 17, 2021 |
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
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210394
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2602_3ab073e6-dfb5-0795-e063-6294a90ab146SPL ID 3ab073e6-dfb5-0795-e063-6294a90ab146SPL set ID d35f8d6b-e642-78bb-e053-2995a90abb2eRxCUI 577033UNII BW9B0ZE037UPC 0368071260236
- 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
N468071260201followed by a unit qualifier and the quantityPackage 68071-2602-01. 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, USP 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 was 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%). Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise ca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210394
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 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-094 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-124 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Proficient Rx LP | 82804-185 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3433 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1963 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | DirectRx | 72189-298 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2537 |
| Sildenafil | Sildenafil citrate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7974 |