NDC codes

FDA NDC Directory
Product NDC (as listed)55150-365Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0365Add 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
55150-365-0155150036501551500365011 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 17, 2022

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)
Amphotericin B
Generic name (nonproprietary)
amphotericin b
Active ingredients
Amphotericin b — 50 mg/12.5mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Eugia US LLCNDC labeler code 55150
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214010
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 55150-365_9f45e5d9-6acd-491e-a80c-f07ecc6ac109SPL ID 9f45e5d9-6acd-491e-a80c-f07ecc6ac109SPL set ID 6f24975c-5191-4fc2-a8da-e57358f8e154RxCUI 967385UNII 7XU7A7DROEUPC 0355150365012
Pharmacologic class
Lipid-based Polyene Antifungal; Polyene Antifungal

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

N455150036501 followed by a unit qualifier and the quantity

Package 55150-0365-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Amphotericin B liposome for injection is indicated for the following: Empirical therapy for presumed fungal infection in febrile, neutropenic patients. Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ). Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55150-365

What is NDC 55150-365?
55150-365 is the product NDC for Amphotericin B, Amphotericin b 50 mg/12.5mL injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amphotericin B.
What is the active ingredient?
Amphotericin b.
Who is the labeler?
Eugia US LLC, NDC labeler code 55150. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amphotericin B?
4 other product NDCs are listed under this name. See all Amphotericin B 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 Amphotericin B NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amphotericin BAmphotericin b 50 mg/1Injectable, LiposomalIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-59423155-0594-31
Amphotericin BAmphotericin b 50 mg/1Injectable, LiposomalIntravenousSun Pharmaceutical Industries, Inc.62756-95462756-0954-0162756-0954-02
Amphotericin BAmphotericin b 50 mg/1Injectable, LiposomalIntravenousSun Pharmaceutical Industries, Inc.62756-23362756-0233-0162756-0233-02
Amphotericin BAmphotericin b 50 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousXGen Pharmaceuticals DJB, Inc.39822-105539822-1055-05

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