What is NDC 13925-522?

13925-522 is the product NDC for Pentamidine Isethionate, Pentamidine isethionate 300 mg/300mg inhalant, listed with the FDA by Seton Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pentamidine Isethionate NDC 13925-522

NDC codes

FDA NDC Directory

Product NDC (as listed)13925-522Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13925-0522Add 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 NDC	11-digit (billing)	Package	Copy
13925-522-01	1392505220113925052201	1 VIAL in 1 CARTON (13925-522-01) / 300 mg in 1 VIALMarketed from Oct 14, 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): Pentamidine Isethionate
Generic name (nonproprietary): pentamidine isethionate
Active ingredients: Pentamidine isethionate — 300 mg/300mg
Dosage form: Inhalant
Route: Respiratory (Inhalation)
Labeler: Seton PharmaceuticalsNDC labeler code 13925
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206667
Marketing start: Oct 14, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 13925-522_d00d85f7-4ea4-4da2-8c13-7ecc598893e6SPL ID d00d85f7-4ea4-4da2-8c13-7ecc598893e6SPL set ID c484f16e-9d97-4416-84a4-8ad8deaf5e19RxCUI 861597UNII 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

N413925052201 followed by a unit qualifier and the quantity

Package 13925-0522-01. 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 Apr 8, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Pentamidine Isethionate 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/mm3. 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 hist…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13925-522

What is NDC 13925-522?: 13925-522 is the product NDC for Pentamidine Isethionate, Pentamidine isethionate 300 mg/300mg inhalant, 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
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	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Seton Pharmaceuticals	13925-515	13925-0515-10

Other NDCs under ANDA 206667

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

FDA NDC Directory listings under ANDA 206667
Product	Strength	Form · route	Labeler	Product NDC
Pentamidine Isethionate	Pentamidine diisethionate 300 mg/300mg	InhalantRespiratory (Inhalation)	PAI Holdings, LLC dba PAI Pharma	0121-1102