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NDC 71288-0554-80 Ganirelix Acetate 250 ug/.5mL Details
Ganirelix Acetate 250 ug/.5mL
Ganirelix Acetate is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is GANIRELIX ACETATE.
Product Information
NDC | 71288-0554 |
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Product ID | 71288-554_faf588af-da1d-4c2b-8122-b02e0aa0bddd |
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, SOLUTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 250 |
Active Ingredient Units | ug/.5mL |
Substance Name | GANIRELIX ACETATE |
Labeler Name | Meitheal 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 | ANDA214996 |
Listing Certified Through | 2024-12-31 |
Package
NDC 71288-0554-80 (71288055480)
NDC Package Code | 71288-554-80 |
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Billing NDC | 71288055480 |
Package | 1 BLISTER PACK in 1 CARTON (71288-554-80) / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS |
Marketing Start Date | 2022-06-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |