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NDC 65219-0028-05 Ganirelix Acetate 250 ug/.5mL Details
Ganirelix Acetate 250 ug/.5mL
Ganirelix Acetate is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is GANIRELIX ACETATE.
Product Information
| NDC | 65219-0028 |
|---|---|
| Product ID | 65219-028_6de9994e-e95e-4cc5-8c50-5c12c23a07b7 |
| Associated GPIs | |
| GCN Sequence Number | 047336 |
| GCN Sequence Number Description | ganirelix acetate SYRINGE 250MCG/0.5 SUBCUT |
| HIC3 | P1N |
| HIC3 Description | LHRH(GNRH) ANTAGONIST,PITUITARY SUPPRESSANT AGENTS |
| GCN | 12283 |
| HICL Sequence Number | 025154 |
| HICL Sequence Number Description | GANIRELIX ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Ganirelix Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ganirelix Acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | ug/.5mL |
| Substance Name | GANIRELIX ACETATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215658 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0028-05 (65219002805)
| NDC Package Code | 65219-028-05 |
|---|---|
| Billing NDC | 65219002805 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2023-03-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |