What is NDC 0548-5001?

0548-5001 is the product NDC for Ganirelix Acetate, Ganirelix acetate 250 ug/.5mL injection, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ganirelix Acetate?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ganirelix Acetate NDC 0548-5001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0548-5001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00548-5001Add 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
0548-5001-00	00548500100	1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGEMarketed from Jun 20, 2022

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): Ganirelix Acetate
Generic name (nonproprietary): ganirelix acetate
Active ingredients: Ganirelix acetate — 250 ug/.5mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Amphastar Pharmaceuticals, Inc.NDC labeler code 0548
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212613
Marketing start: Jun 20, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased GnRH Secretion (Physiologic effect)Gonadotropin Releasing Hormone Receptor Antagonists (Mechanism)
Identifiers: Product ID 0548-5001_0e71b74d-723d-46a4-b2e5-7c7157949ad4SPL ID 0e71b74d-723d-46a4-b2e5-7c7157949ad4SPL set ID 9c286f64-8039-44ec-8fdd-d1a2f52b4c3cRxCUI 855200UNII 56U7906FQW
Pharmacologic class: Gonadotropin Releasing Hormone Receptor Antagonist

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

N400548500100 followed by a unit qualifier and the quantity

Package 00548-5001-00. 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 Apr 19, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0548-5001

What is NDC 0548-5001?: 0548-5001 is the product NDC for Ganirelix Acetate, Ganirelix acetate 250 ug/.5mL injection, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ganirelix Acetate.
What is the active ingredient?: Ganirelix acetate.
Who is the labeler?: Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ganirelix Acetate?: 8 other product NDCs are listed under this name. See all Ganirelix 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 Ganirelix Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	Injection, SolutionSubcutaneous	Mullan Pharmaceutical Inc.	83301-0082	83301-0082-01
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	Injection, SolutionSubcutaneous	Qilu Pharmaceutical Co., Ltd.	67184-0574	67184-0574-01
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	InjectionSubcutaneous	Xiromed LLC	70700-327	70700-0327-98
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	Injection, SolutionSubcutaneous	Lupin Pharmaceuticals, Inc.	70748-274	70748-0274-01
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	InjectionSubcutaneous	Fresenius Kabi USA, LLC	65219-028	65219-0028-05
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	Injection, SolutionSubcutaneous	Gland Pharma Limited	68083-472	68083-0472-01
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	Injection, SolutionSubcutaneous	Meitheal Pharmaceuticals Inc.	71288-554	71288-0554-80
Ganirelix Acetate	Ganirelix acetate 250 ug/.5mL	Injection, SolutionSubcutaneous	Organon LLC	78206-138	78206-0138-0178206-0138-02