Prescription drug · ANDA
Sildenafil Citrate NDC 67877-648
Sildenafil citrate 10 mg/mL · Powder, For suspension · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-648-11 | 67877064811 | 1 BOTTLE, GLASS in 1 CARTON (67877-648-11) / 112 mL in 1 BOTTLE, GLASSMarketed from Nov 29, 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 Citrate
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 10 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212440
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-648_a85cb8be-4aea-410c-a921-15d44a6ff48aSPL ID a85cb8be-4aea-410c-a921-15d44a6ff48aSPL set ID a0fa4162-e1b7-4293-ab7d-c5b375779060RxCUI 1307427UNII BW9B0ZE037UPC 0367877648118
- 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
N467877064811followed by a unit qualifier and the quantityPackage 67877-0648-11. 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 )]. Additional information is approved for Viatris Specialty LLC's REVATIO ® (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil for Oral Suspension 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…
Excerpt only. Read the full label for complete information.