What is NDC 0143-9550?

0143-9550 is the product NDC for Daunorubicin Hydrochloride, Daunorubicin hydrochloride 5 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Daunorubicin Hydrochloride?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Daunorubicin Hydrochloride NDC 0143-9550

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9550Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9550Add 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 NDC	11-digit (billing)	Package	Copy
0143-9550-01	0014395500100143955001	1 VIAL in 1 CARTON (0143-9550-01) / 10 mL in 1 VIALMarketed from Jan 2, 2018

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): Daunorubicin Hydrochloride
Generic name (nonproprietary): daunorubicin hydrochloride
Active ingredients: Daunorubicin hydrochloride — 5 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050731
Marketing start: Jan 2, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0143-9550_d77dc365-6db8-4bdc-81fc-7ac80bcc7699SPL ID d77dc365-6db8-4bdc-81fc-7ac80bcc7699SPL set ID 227784a8-ce68-4dd4-8ac5-a65265969677RxCUI 309650, 2002002UNII UD984I04LZ
Pharmacologic class: Anthracycline Topoisomerase Inhibitor

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

N400143955001 followed by a unit qualifier and the quantity

Package 00143-9550-01. 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 Feb 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9550

What is NDC 0143-9550?: 0143-9550 is the product NDC for Daunorubicin Hydrochloride, Daunorubicin hydrochloride 5 mg/mL injection, 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?: Daunorubicin Hydrochloride.
What is the active ingredient?: Daunorubicin 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 Daunorubicin Hydrochloride?: 4 other product NDCs are listed under this name. See all Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
daunorubicin hydrochloride	Daunorubicin hydrochloride 5 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-182	71288-0182-05
Daunorubicin Hydrochloride	Daunorubicin hydrochloride 5 mg/mL	Injection, SolutionIntravenous	Hisun Pharmaceuticals USA, Inc.	42658-019	42658-0019-01
Daunorubicin Hydrochloride	Daunorubicin hydrochloride 5 mg/mL	Injection, SolutionIntravenous	Hisun Pharmaceuticals USA, Inc.	42658-021	42658-0021-0142658-0021-02
Daunorubicin Hydrochloride	Daunorubicin hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9551	00143-9551-10

Other NDCs under NDA 050731

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

FDA NDC Directory listings under NDA 050731
Product	Strength	Form · route	Labeler	Product NDC
Daunorubicin Hydrochloride	Daunorubicin hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9551