What is NDC 42023-259?

42023-259 is the product NDC for Leuprolide Acetate, Leuprolide acetate 1 mg/.2mL injection, listed with the FDA by Endo USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Endo USA, Inc., NDC labeler code 42023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Leuprolide Acetate?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Leuprolide Acetate NDC 42023-259 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42023-259Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42023-0259Add 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
42023-259-00	4202302590042023025900	1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 30, 2026

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): Leuprolide Acetate
Generic name (nonproprietary): leuprolide acetate
Active ingredients: Leuprolide acetate — 1 mg/.2mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Endo USA, Inc.NDC labeler code 42023
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217437
Marketing start: Jun 30, 2026
Listing expires: Dec 31, 2026
Other FDA classes: Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 42023-259_6d6d8948-a606-4928-a013-e56a24ac32d7SPL ID 6d6d8948-a606-4928-a013-e56a24ac32d7SPL set ID 290b0716-2fd5-43a1-8d3c-4857c1b2eefaRxCUI 545835UNII 37JNS02E7V
Pharmacologic class: Gonadotropin Releasing Hormone Receptor Agonist

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

N442023025900 followed by a unit qualifier and the quantity

Package 42023-0259-00. 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 Jun 10, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42023-259

What is NDC 42023-259?: 42023-259 is the product NDC for Leuprolide Acetate, Leuprolide acetate 1 mg/.2mL injection, listed with the FDA by Endo USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Leuprolide Acetate.
What is the active ingredient?: Leuprolide acetate.
Who is the labeler?: Endo USA, Inc., NDC labeler code 42023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leuprolide Acetate?: 11 other product NDCs are listed under this name. See all Leuprolide Acetate 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 Leuprolide Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Leuprolide Acetate	—	Kit	Zydus Pharmaceuticals USA Inc.	70710-1769	70710-1769-03
Leuprolide Acetate	—	Kit	Zydus Lifesciences Limited	70771-1687	70771-1687-03
leuprolide acetate	—	KitSubcutaneous	PAI Holdings, LLC dba PAI Pharma	0121-2106	00121-2106-02
leuprolide acetate	—	KitSubcutaneous	UBI Pharma Inc.	72843-591	72843-0591-99
Leuprolide Acetate	—	KitSubcutaneous	Meitheal Pharmaceuticals Inc	71288-569	71288-0569-90
Leuprolide Acetate	—	KitSubcutaneous	NorthStar RxLLC	72603-344	72603-0344-01
leuprolide acetate	—	KitSubcutaneous	Amneal Pharmaceuticals LLC	70121-2537	70121-2537-06
Leuprolide Acetate	—	Kit	Eugia US LLC	55150-478	55150-0478-01
Leuprolide Acetate	—	Kit	VGYAAN Pharmaceuticals LLC	72664-611	72664-0611-28
leuprolide acetate	—	Kit	Sun Pharmaceutical Industries, Inc.	47335-936	47335-0936-40

All 12 Leuprolide Acetate NDCs