Prescription drug · ANDA
Ganirelix Acetate NDC 67184-0574
Ganirelix acetate 250 ug/.5mL · Injection, Solution · Subcutaneous · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-0574-1 | 67184057401 | 1 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
- 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.
- NDC on a medical claim
N467184057401followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 218855
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ganirelix Acetate | Ganirelix acetate 250 ug/.5mL | Injection, SolutionSubcutaneous | Mullan Pharmaceutical Inc. | 83301-0082 |