NDC codes

FDA NDC Directory
Product NDC (as listed)55150-434Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0434Add 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
55150-434-0255150043402551500434021 KIT in 1 PACKAGE (55150-434-02) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02) * 25 mL in 1 VIAL (55150-433-02)Marketed from May 12, 2016

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
Dosage form
Kit
Labeler
Eugia US LLCNDC labeler code 55150
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200752
Marketing start
Listing expires
Identifiers
Product ID 55150-434_18fc9e08-fcd5-4e1a-ad6e-f531664af613SPL ID 18fc9e08-fcd5-4e1a-ad6e-f531664af613SPL set ID cb72203a-0b09-42d5-bf51-7f479feb3adbRxCUI 1736585

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.

NDC on a medical claim

N455150043402 followed by a unit qualifier and the quantity

Package 55150-0434-02. 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 continue…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55150-434

What is NDC 55150-434?
55150-434 is the product NDC for Dexrazoxane kit, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dexrazoxane.
Who is the labeler?
Eugia US LLC, NDC labeler code 55150. 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 solutionIntravenousFosun Pharma USA Inc.72266-10172266-0101-01
Dexrazoxanedexrazoxane for injectionDexrazoxane hydrochloride 500 mg/50mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-19568083-0195-01
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 200752

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

FDA NDC Directory listings under ANDA 200752
ProductStrengthForm · routeLabelerProduct NDC
Dexrazoxane—KitEugia US LLC55150-437

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