Prescription drug · NDA
NebuPent (Pentamidine isethionate) NDC 63323-877
Pentamidine isethionate 300 mg/6mL · Inhalant · Respiratory (Inhalation) · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-877-15 | 63323087715 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 15, 2011 |
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)
- NebuPent
- Generic name (nonproprietary)
- pentamidine isethionate
- Active ingredients
- Pentamidine isethionate — 300 mg/6mL
- Dosage form
- Inhalant
- Route
- Respiratory (Inhalation)
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019887
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-877_d673c124-d95f-4751-a11a-a26de8740b3aSPL ID d673c124-d95f-4751-a11a-a26de8740b3aSPL set ID e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccbRxCUI 861597, 861599UNII V2P3K60DA2
- Pharmacologic class
- Antiprotozoal
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463323087715followed by a unit qualifier and the quantityPackage 63323-0877-15. 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)
INDICATIONS AND USAGE: NebuPent is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP i…
Excerpt only. Read the full label for complete information.
About NDC 63323-877
- What is NDC 63323-877?
- 63323-877 is the product NDC for NebuPent (pentamidine isethionate), Pentamidine isethionate 300 mg/6mL inhalant, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- NebuPent (Pentamidine isethionate).
- What is the active ingredient?
- Pentamidine isethionate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for NebuPent?
- 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.