Prescription drug · ANDA
Amphotericin B NDC 39822-1055
Amphotericin b 50 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · XGen Pharmaceuticals DJB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39822-1055-5 | 39822105505 | 10 mL in 1 VIAL (39822-1055-5)Marketed from Apr 29, 1992 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- XGen Pharmaceuticals DJB, Inc.NDC labeler code 39822
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 063206
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 39822-1055_ff6c6de5-ba12-4176-817f-359761f6e4bfSPL ID ff6c6de5-ba12-4176-817f-359761f6e4bfSPL set ID a0a54943-9ce4-4f3e-b681-a1a9144c16ceRxCUI 239240UNII 7XU7A7DROE
- 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
N439822105505followed by a unit qualifier and the quantityPackage 39822-1055-05. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS & USAGE Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia , Mucor and Rhizop…
Excerpt only. Read the full label for complete information.
About NDC 39822-1055
- What is NDC 39822-1055?
- 39822-1055 is the product NDC for Amphotericin B, Amphotericin b 50 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by XGen Pharmaceuticals DJB, Inc.. 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?
- XGen Pharmaceuticals DJB, Inc., NDC labeler code 39822. 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/1 | Injectable, LiposomalIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-954 | 62756-0954-0162756-0954-02 |
| 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 |