Prescription drug · ANDA
Ganirelix Acetate NDC 0548-5001
Ganirelix acetate 250 ug/.5mL · Injection · Subcutaneous · Amphastar Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212613
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N400548500100followed by a unit qualifier and the quantityPackage 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 .
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.