NDC codes

FDA NDC Directory
Product NDC (as listed)68462-560Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0560Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68462-560-4768462056047684620560471 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

N468462056047 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 201587
ProductStrengthForm · routeLabelerProduct NDC
MupirocinMupirocin calcium 2 g/100gCreamTopicalGlenmark Pharmaceuticals Inc., USA68462-564

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