Prescription drug · ANDA
Pentamidine Isethionate NDC 13925-515
Pentamidine isethionate 300 mg/300mg · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Seton Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13925-515-10 | 1392505151013925051510 | 10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIALMarketed from Apr 1, 2018 |
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)
- Pentamidine Isethionate
- Generic name (nonproprietary)
- pentamidine isethionate
- Active ingredients
- Pentamidine isethionate — 300 mg/300mg
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Seton PharmaceuticalsNDC labeler code 13925
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206666
- Marketing start
- Listing expires
- Identifiers
- Product ID 13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371SPL ID c83ced5f-9bf2-4367-9146-5b17d0b83371SPL set ID cb8e8155-5505-44d5-9dee-525e2e45b95dRxCUI 861601UNII V2P3K60DA2UPC 0313925515109
- 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N413925051510followed by a unit qualifier and the quantityPackage 13925-0515-10. 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)
INDICATIONS AND USAGE Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.
Excerpt only. Read the full label for complete information.
About NDC 13925-515
- What is NDC 13925-515?
- 13925-515 is the product NDC for Pentamidine Isethionate, Pentamidine isethionate 300 mg/300mg injection, powder, lyophilized, for solution, listed with the FDA by Seton Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pentamidine Isethionate.
- What is the active ingredient?
- Pentamidine isethionate.
- Who is the labeler?
- Seton Pharmaceuticals, NDC labeler code 13925. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pentamidine Isethionate?
- 5 other product NDCs are listed under this name. See all Pentamidine Isethionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pentamidine Isethionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pentamidine Isethionate | Pentamidine diisethionate 300 mg/300mg | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1101 | 00121-1101-02 |
| Pentamidine Isethionate | Pentamidine diisethionate 300 mg/300mg | InhalantRespiratory (Inhalation) | PAI Holdings, LLC dba PAI Pharma | 0121-1102 | 00121-1102-55 |
| Pentamidine Isethionate | Pentamidine isethionate 300 mg/6mL | InhalantRespiratory (Inhalation) | XGen Pharmaceuticals DJB, Inc. | 39822-3030 | 39822-3030-02 |
| pentamidine isethionate | Pentamidine isethionate 300 mg/300mg | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-748 | 23155-0748-41 |
| Pentamidine Isethionate | Pentamidine isethionate 300 mg/300mg | InhalantRespiratory (Inhalation) | Seton Pharmaceuticals | 13925-522 | 13925-0522-01 |
Other NDCs under ANDA 206666
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 |
|---|---|---|---|---|
| Pentamidine Isethionate | Pentamidine diisethionate 300 mg/300mg | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1101 |