Prescription drug · ANDA
Pirnuo (Mupirocin) NDC 68462-560
Mupirocin calcium 2 g/100g · Cream · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-560-47 | 6846205604768462056047 | 1 BOTTLE in 1 CARTON (68462-560-47) / 42.5 g in 1 BOTTLEMarketed from Jul 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)
- Pirnuo
- Generic name (nonproprietary)
- mupirocin
- Active ingredients
- Mupirocin calcium — 2 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201587
- Marketing start
- Listing expires
- Other FDA classes
- RNA Synthetase Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-560_dc6f3960-2e28-46f1-8619-de5aee5f97adSPL ID dc6f3960-2e28-46f1-8619-de5aee5f97adSPL set ID 89c43f7b-1a88-45bf-a356-07518d4e7870RxCUI 311877, 2286614UNII RG38I2P540UPC 0368462560471
- Pharmacologic class
- RNA Synthetase Inhibitor Antibacterial
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468462056047followed by a unit qualifier and the quantityPackage 68462-0560-47. 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)
PIRNUO cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes). PIRNUO cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68462-560
- What is NDC 68462-560?
- 68462-560 is the product NDC for Pirnuo (mupirocin), Mupirocin calcium 2 g/100g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pirnuo (Mupirocin).
- What is the active ingredient?
- Mupirocin calcium.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pirnuo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 201587
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 |
|---|---|---|---|---|
| Mupirocin | Mupirocin calcium 2 g/100g | CreamTopical | Glenmark Pharmaceuticals Inc., USA | 68462-564 |