What is NDC 71288-569?

71288-569 is the product NDC for Leuprolide Acetate kit, listed with the FDA by Meitheal Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Meitheal Pharmaceuticals Inc, NDC labeler code 71288. 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 71288-569 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-569Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0569Add 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
71288-569-90	7128805699071288056990	1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)Marketed from May 15, 2024

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
Dosage form: Kit
Route: Subcutaneous
Labeler: Meitheal Pharmaceuticals IncNDC labeler code 71288
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075471
Marketing start: May 15, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 71288-569_4fc2b983-6691-4203-90a1-a48e144e4b3dSPL ID 4fc2b983-6691-4203-90a1-a48e144e4b3dSPL set ID d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584RxCUI 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.

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

N471288056990 followed by a unit qualifier and the quantity

Package 71288-0569-90. 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 23, 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 71288-569

What is NDC 71288-569?: 71288-569 is the product NDC for Leuprolide Acetate kit, listed with the FDA by Meitheal Pharmaceuticals 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?: Meitheal Pharmaceuticals Inc, NDC labeler code 71288. 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	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