NDC codes

FDA NDC Directory
Product NDC (as listed)62756-954Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62756-0954Add 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
62756-954-01627560954011 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 2024
62756-954-026275609540210 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 2024

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/1
Dosage form
Injectable, Liposomal
Route
Intravenous
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212514
Marketing start
Listing expires
Other FDA classes
Polyenes (Chemical structure)
Identifiers
Product ID 62756-954_4acdbb90-5e56-4ab9-8a37-5dbeabc9c669SPL ID 4acdbb90-5e56-4ab9-8a37-5dbeabc9c669SPL set ID 02aadef1-390b-4270-b56d-33452eb89ddeRxCUI 967385UNII 7XU7A7DROEUPC 0362756954014
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

N462756095401 followed by a unit qualifier and the quantity

Package 62756-0954-01. 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 62756-954

What is NDC 62756-954?
62756-954 is the product NDC for Amphotericin B, Amphotericin b 50 mg/1 injectable, liposomal, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. 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/12.5mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-36555150-0365-01
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

Other NDCs under ANDA 212514

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

FDA NDC Directory listings under ANDA 212514
ProductStrengthForm · routeLabelerProduct NDC
Amphotericin BAmphotericin b 50 mg/1Injectable, LiposomalIntravenousSun Pharmaceutical Industries, Inc.62756-233

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