What is NDC 0143-9217?

0143-9217 is the product NDC for Idarubicin Hydrochloride, Idarubicin hydrochloride 1 mg/mL injection, solution, 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 Idarubicin Hydrochloride?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Idarubicin Hydrochloride NDC 0143-9217

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9217Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9217Add 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
0143-9217-01	0014392170100143921701	1 VIAL, GLASS in 1 BOX (0143-9217-01) / 5 mL in 1 VIAL, GLASSMarketed from Jan 30, 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): Idarubicin Hydrochloride
Generic name (nonproprietary): idarubicin hydrochloride
Active ingredients: Idarubicin hydrochloride — 1 mg/mL
Dosage form: Injection, 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 065275
Marketing start: Jan 30, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0143-9217_894003f2-e5ea-430f-9450-aae8a493664eSPL ID 894003f2-e5ea-430f-9450-aae8a493664eSPL set ID b9b337d5-50f7-4ea9-9df4-72c86e4c0b91RxCUI 1791493, 1791498, 1791500UNII 5VV3MDU5IE
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

N400143921701 followed by a unit qualifier and the quantity

Package 00143-9217-01. 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 Apr 19, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Idarubicin Hydrochloride injection, USP in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9217

What is NDC 0143-9217?: 0143-9217 is the product NDC for Idarubicin Hydrochloride, Idarubicin hydrochloride 1 mg/mL injection, 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?: Idarubicin Hydrochloride.
What is the active ingredient?: Idarubicin 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 Idarubicin Hydrochloride?: 8 other product NDCs are listed under this name. See all Idarubicin 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 Idarubicin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-184	71288-0184-05
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-185	71288-0185-10
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-186	71288-0186-20
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9306	00143-9306-01
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9307	00143-9307-01
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9308	00143-9308-01
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9218	00143-9218-01
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9219	00143-9219-01

Other NDCs under ANDA 065275

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

FDA NDC Directory listings under ANDA 065275
Product	Strength	Form · route	Labeler	Product NDC
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9218
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9219
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9306
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9307
Idarubicin Hydrochloride	Idarubicin hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9308