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NDC 55566-1010-01 Fyremadel 250 ug/.5mL Details
Fyremadel 250 ug/.5mL
Fyremadel is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is GANIRELIX ACETATE.
Product Information
| NDC | 55566-1010 |
|---|---|
| Product ID | 55566-1010_46eadc24-f279-48a3-a321-bfd70591f3ac |
| Associated GPIs | 3009004010E520 |
| 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 | Fyremadel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ganirelix acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | ug/.5mL |
| Substance Name | GANIRELIX ACETATE |
| Labeler Name | Ferring Pharmaceuticals Inc. |
| 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 | ANDA204246 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55566-1010-01 (55566101001)
| NDC Package Code | 55566-1010-1 |
|---|---|
| Billing NDC | 55566101001 |
| Package | 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE |
| Marketing Start Date | 2022-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |