What is NDC 0121-1101?

0121-1101 is the product NDC for Pentamidine Isethionate, Pentamidine diisethionate 300 mg/300mg injection, powder, lyophilized, for solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 0121-1101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1101Add 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
0121-1101-02	00121110102	10 VIAL, SINGLE-USE in 1 CARTON (0121-1101-02) / 300 mg in 1 VIAL, SINGLE-USE (0121-1101-55)Marketed from Jun 12, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 diisethionate — 300 mg/300mg
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular, Intravenous
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206666
Marketing start: Jun 12, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 0121-1101_f1a6483e-a7cf-4b6e-9372-458a0a8982f9SPL ID f1a6483e-a7cf-4b6e-9372-458a0a8982f9SPL set ID d46aea4f-8f3f-4ce0-93d6-94e147f5a31aRxCUI 861601UNII V2P3K60DA2UPC 0301211101556
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

N400121110102 followed by a unit qualifier and the quantity

Package 00121-1101-02. 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 May 7, 2026.

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 0121-1101

What is NDC 0121-1101?: 0121-1101 is the product NDC for Pentamidine Isethionate, Pentamidine diisethionate 300 mg/300mg injection, powder, lyophilized, for solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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 diisethionate.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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	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
Pentamidine Isethionate	Pentamidine isethionate 300 mg/300mg	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Seton Pharmaceuticals	13925-515	13925-0515-10

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
Product	Strength	Form · route	Labeler	Product NDC
Pentamidine Isethionate	Pentamidine isethionate 300 mg/300mg	Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous	Seton Pharmaceuticals	13925-515