NDC codes

FDA NDC Directory
Product NDC (as listed)13925-515Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13925-0515Add 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
13925-515-10139250515101392505151010 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.

How CPT relates to drug billing

NDC on a medical claim

N413925051510 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pentamidine Isethionate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pentamidine IsethionatePentamidine diisethionate 300 mg/300mgInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousPAI Holdings, LLC dba PAI Pharma0121-110100121-1101-02
Pentamidine IsethionatePentamidine diisethionate 300 mg/300mgInhalantRespiratory (Inhalation)PAI Holdings, LLC dba PAI Pharma0121-110200121-1102-55
Pentamidine IsethionatePentamidine isethionate 300 mg/6mLInhalantRespiratory (Inhalation)XGen Pharmaceuticals DJB, Inc.39822-303039822-3030-02
pentamidine isethionatePentamidine isethionate 300 mg/300mgInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-74823155-0748-41
Pentamidine IsethionatePentamidine isethionate 300 mg/300mgInhalantRespiratory (Inhalation)Seton Pharmaceuticals13925-52213925-0522-01

Other NDCs under ANDA 206666

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206666
ProductStrengthForm · routeLabelerProduct NDC
Pentamidine IsethionatePentamidine diisethionate 300 mg/300mgInjection, Powder, Lyophilized, For solutionIntramuscular, IntravenousPAI Holdings, LLC dba PAI Pharma0121-1101

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