Prescription drug · ANDA

Dexrazoxane (Dexrazoxane for injection) NDC 72266-101

Dexrazoxane hydrochloride 500 mg/50mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fosun Pharma USA Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)72266-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72266-0101Add 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
72266-101-0172266010101722660101011 VIAL in 1 CARTON (72266-101-01) / 50 mL in 1 VIALMarketed from Mar 18, 2019

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)
Dexrazoxane
Generic name (nonproprietary)
dexrazoxane for injection
Active ingredients
Dexrazoxane hydrochloride — 500 mg/50mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Fosun Pharma USA Inc.NDC labeler code 72266
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207321
Marketing start
Listing expires
Identifiers
Product ID 72266-101_39134f54-58a4-ca41-e063-6394a90ac300SPL ID 39134f54-58a4-ca41-e063-6394a90ac300SPL set ID c1d98fbe-5fd9-4518-b1a5-fac92e32928fRxCUI 1736585, 1736590UNII 5346058Q7SUPC 0372266101013, 0372266235015
Pharmacologic class
Cytoprotective Agent

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

N472266010101 followed by a unit qualifier and the quantity

Package 72266-0101-01. 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)

Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions ( 5.2 )] . Dexrazoxane for injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72266-101

What is NDC 72266-101?
72266-101 is the product NDC for Dexrazoxane (dexrazoxane for injection), Dexrazoxane hydrochloride 500 mg/50mL injection, powder, lyophilized, for solution, listed with the FDA by Fosun Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dexrazoxane (Dexrazoxane for Injection).
What is the active ingredient?
Dexrazoxane hydrochloride.
Who is the labeler?
Fosun Pharma USA Inc., NDC labeler code 72266. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexrazoxane?
10 other product NDCs are listed under this name. See all Dexrazoxane 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 Dexrazoxane NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DexrazoxaneDexrazoxane hydrochloride 250 mg/25mLInjection, Powder, Lyophilized, For solutionIntravenousNovadoz Pharmaceuticals LLC72205-24772205-0247-01
DexrazoxaneDexrazoxane hydrochloride 500 mg/50mLInjection, Powder, Lyophilized, For solutionIntravenousNovadoz Pharmaceuticals LLC72205-24872205-0248-01
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 500 mg/50mLInjection, Powder, Lyophilized, For solutionIntravenousAlmaject, Inc.72611-71672611-0716-72
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 250 mg/25mLInjection, Powder, Lyophilized, For solutionIntravenousFosun Pharma USA Inc.72266-23572266-0235-01
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 250 mg/25mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-38868083-0388-01
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 500 mg/50mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-19568083-0195-01
Dexrazoxane—KitEugia US LLC55150-43455150-0434-02
Dexrazoxane—KitEugia US LLC55150-43755150-0437-01
DexrazoxaneDexrazoxane hydrochloride 250 mg/1Injection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-924700143-9247-01
DexrazoxaneDexrazoxane hydrochloride 500 mg/1Injection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-924800143-9248-01

Other NDCs under ANDA 207321

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

FDA NDC Directory listings under ANDA 207321
ProductStrengthForm · routeLabelerProduct NDC
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 500 mg/50mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-195
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 250 mg/25mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-388
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 250 mg/25mLInjection, Powder, Lyophilized, For solutionIntravenousFosun Pharma USA Inc.72266-235
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 500 mg/50mLInjection, Powder, Lyophilized, For solutionIntravenousAlmaject, Inc.72611-716

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