What is NDC 0781-4003?

0781-4003 is the product NDC for Leuprolide Acetate kit, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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 0781-4003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-4003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-4003Add 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
0781-4003-32	0078140033200781400332	1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKETMarketed from Aug 4, 1998

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): Leuprolide Acetate
Generic name (nonproprietary): leuprolide acetate
Dosage form: Kit
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074728
Marketing start: Aug 4, 1998
Listing expires: Dec 31, 2027
Identifiers: Product ID 0781-4003_e75789aa-7d4c-4107-b140-b24686874a36SPL ID e75789aa-7d4c-4107-b140-b24686874a36SPL set ID 8bd72c1e-2751-4498-a346-bc5e3acbba0bRxCUI 545835, 797544

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.

NDC on a medical claim

N400781400332 followed by a unit qualifier and the quantity

Package 00781-4003-32. 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 May 19, 2026.

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 0781-4003

What is NDC 0781-4003?: 0781-4003 is the product NDC for Leuprolide Acetate kit, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Leuprolide Acetate.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. 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	Leuprolide acetate 1 mg/.2mL	InjectionSubcutaneous	Endo USA, Inc.	42023-259	42023-0259-00
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

All 12 Leuprolide Acetate NDCs