Daunorubicin Hydrochloride NDC 42658-021

NDC codes

FDA NDC Directory

Product NDC (as listed)42658-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42658-0021Add 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
42658-021-01	42658002101	1 VIAL in 1 BOX (42658-021-01) / 4 mL in 1 VIALMarketed from Jan 20, 2020
42658-021-02	42658002102	10 VIAL in 1 CARTON (42658-021-02) / 4 mL in 1 VIALMarketed from Jan 27, 2021

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): Daunorubicin Hydrochloride
Generic name (nonproprietary): daunorubicin hydrochloride
Active ingredients: Daunorubicin hydrochloride — 5 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Hisun Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208759
Marketing start: Jan 20, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 42658-021_48b4337a-9cc5-665d-e063-6294a90a1613SPL ID 48b4337a-9cc5-665d-e063-6294a90a1613SPL set ID 9705fa12-499e-41a3-8fb4-f6df0858b851RxCUI 309650, 2002002UNII UD984I04LZUPC 0342658021014, 0342658019011
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

N442658002101 followed by a unit qualifier and the quantity

Package 42658-0021-01. 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 Jan 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Daunorubicin hydrochloride injection 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)

Other NDCs under ANDA 208759

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

FDA NDC Directory listings under ANDA 208759
Product	Strength	Form · route	Labeler	Product NDC
Daunorubicin Hydrochloride	Daunorubicin hydrochloride 5 mg/mL	Injection, SolutionIntravenous	Hisun Pharmaceuticals USA, Inc.	42658-019