Prescription drug · ANDA
Amphotericin B NDC 62756-954
Amphotericin b 50 mg/1 · Injectable, Liposomal · Intravenous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-954-01 | 62756095401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 2024 | |
| 62756-954-02 | 62756095402 | 10 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.
- NDC on a medical claim
N462756095401followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Amphotericin B products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amphotericin B | Amphotericin b 50 mg/1 | Injectable, LiposomalIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-594 | 23155-0594-31 |
| Amphotericin B | Amphotericin b 50 mg/12.5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Eugia US LLC | 55150-365 | 55150-0365-01 |
| Amphotericin B | Amphotericin b 50 mg/1 | Injectable, LiposomalIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-233 | 62756-0233-0162756-0233-02 |
| Amphotericin B | Amphotericin b 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | XGen Pharmaceuticals DJB, Inc. | 39822-1055 | 39822-1055-05 |
Other NDCs under ANDA 212514
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amphotericin B | Amphotericin b 50 mg/1 | Injectable, LiposomalIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-233 |