Prescription drug · ANDA
Sildenafil (sildenafil citrate) NDC 70954-168
Sildenafil citrate 10 mg/mL · For suspension · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-168-10 | 70954016810 | 1 BOTTLE in 1 CARTON (70954-168-10) / 112 mL in 1 BOTTLEMarketed from May 31, 2019 |
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
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 10 mg/mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212260
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-168_7e36fae8-7fbe-44fe-a951-66f18f1b3fe1SPL ID 7e36fae8-7fbe-44fe-a951-66f18f1b3fe1SPL set ID 083da718-e934-4941-b083-a19b4ebe3935RxCUI 1307427UNII BW9B0ZE037UPC 0370954168102
- 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
N470954016810followed by a unit qualifier and the quantityPackage 70954-0168-10. 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 for oral suspension is 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) for Oral Suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information Adults Sildenafil is 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 del…
Excerpt only. Read the full label for complete information.