NDC codes

FDA NDC Directory
Product NDC (as listed)39822-1055Labeler and product segments. Claims need a package NDC.
Product NDC at billing width39822-1055Add 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
39822-1055-53982210550510 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.

How CPT relates to drug billing

NDC on a medical claim

N439822105505 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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/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

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