NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9248Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9248Add 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
0143-9248-0100143924801001439248011 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Oct 5, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Active ingredients
Dexrazoxane hydrochloride — 500 mg/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076068
Marketing start
Listing expires
Identifiers
Product ID 0143-9248_032583c8-f4e7-4105-b92e-b5c3f96ca80eSPL ID 032583c8-f4e7-4105-b92e-b5c3f96ca80eSPL set ID 68089182-d4a2-4053-8d0d-fc97a901515dRxCUI 1736585, 1736590UNII 5346058Q7S
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

N400143924801 followed by a unit qualifier and the quantity

Package 00143-9248-01. 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)

About NDC 0143-9248

What is NDC 0143-9248?
0143-9248 is the product NDC for Dexrazoxane, Dexrazoxane hydrochloride 500 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dexrazoxane.
What is the active ingredient?
Dexrazoxane hydrochloride.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 LLC55150-43455150-0434-02
Dexrazoxane—KitEugia US LLC55150-43755150-0437-01
DexrazoxaneDexrazoxane hydrochloride 250 mg/1Injection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-924700143-9247-01

Other NDCs under ANDA 076068

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

FDA NDC Directory listings under ANDA 076068
ProductStrengthForm · routeLabelerProduct NDC
DexrazoxaneDexrazoxane hydrochloride 250 mg/1Injection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-9247

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