NDC codes

FDA NDC Directory
Product NDC (as listed)67184-0574Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67184-0574Add 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 NDC11-digit (billing)PackageCopy
67184-0574-167184057401671840574011 BLISTER PACK in 1 CARTON (67184-0574-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASSMarketed from May 15, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Solution
Route
Subcutaneous
Labeler
Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218855
Marketing start
Listing expires
Other FDA classes
Decreased GnRH Secretion (Physiologic effect)Gonadotropin Releasing Hormone Receptor Antagonists (Mechanism)
Identifiers
Product ID 67184-0574_edcb57c8-5b08-4076-b67c-93d6d610525dSPL ID edcb57c8-5b08-4076-b67c-93d6d610525dSPL set ID 440f6d67-f02e-4407-8830-39c394e25e5dRxCUI 855200UNII 56U7906FQWUPC 0367184057412
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

N467184057401 followed by a unit qualifier and the quantity

Package 67184-0574-01. 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 .

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 67184-0574

What is NDC 67184-0574?
67184-0574 is the product NDC for Ganirelix Acetate, Ganirelix acetate 250 ug/.5mL injection, solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. 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?
Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjection, SolutionSubcutaneousMullan Pharmaceutical Inc.83301-008283301-0082-01
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjectionSubcutaneousXiromed LLC70700-32770700-0327-98
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjection, SolutionSubcutaneousLupin Pharmaceuticals, Inc.70748-27470748-0274-01
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjectionSubcutaneousFresenius Kabi USA, LLC65219-02865219-0028-05
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjection, SolutionSubcutaneousGland Pharma Limited68083-47268083-0472-01
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjectionSubcutaneousAmphastar Pharmaceuticals, Inc.0548-500100548-5001-00
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjection, SolutionSubcutaneousMeitheal Pharmaceuticals Inc.71288-55471288-0554-80
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjection, SolutionSubcutaneousOrganon LLC78206-13878206-0138-02

Other NDCs under ANDA 218855

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

FDA NDC Directory listings under ANDA 218855
ProductStrengthForm · routeLabelerProduct NDC
Ganirelix AcetateGanirelix acetate 250 ug/.5mLInjection, SolutionSubcutaneousMullan Pharmaceutical Inc.83301-0082

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