NDC codes

FDA NDC Directory
Product NDC (as listed)55150-437Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0437Add 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
55150-437-01551500437011 KIT in 1 PACKAGE (55150-437-01) * 50 mL in 1 VIAL, SINGLE-DOSE (55150-435-01) * 50 mL in 1 VIAL (55150-436-01)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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200752
Marketing start
Listing expires
Identifiers
Product ID 55150-437_f0a2a9ff-2f1f-481b-96c8-404e9d4a60faSPL ID f0a2a9ff-2f1f-481b-96c8-404e9d4a60faSPL set ID be9ac1e9-21a9-439a-9029-9f03513220eaRxCUI 1736585, 1736590

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

N455150043701 followed by a unit qualifier and the quantity

Package 55150-0437-01. 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 continue…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 LLC55150-434
Dexrazoxane—KitEugia US LLC55150-434

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in