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NDC 75987-0130-15 TEPEZZA 500 mg/1 Details
TEPEZZA 500 mg/1
TEPEZZA is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is TEPROTUMUMAB.
MedlinePlus Drug Summary
Teprotumumab-trbw injection is used to treat thyroid eye disease (TED; Graves' eye disease; a disorder in which the immune system causes inflammation and swelling behind the eye). Teprotumumab-trbw is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in the body that causes inflammation in the eye.
Related Packages: 75987-0130-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Teprotumumab-trbw Injection
Product Information
| NDC | 75987-0130 |
|---|---|
| Product ID | 75987-130_8d1559f0-64a5-4c69-8818-c31f248c9b5f |
| Associated GPIs | 30192070402120 |
| GCN Sequence Number | 080659 |
| GCN Sequence Number Description | teprotumumab-trbw VIAL 500 MG INTRAVEN |
| HIC3 | Z6B |
| HIC3 Description | INSULIN-LIKE GROWTH FACTOR RECEPTOR (IGF-R) INHIB |
| GCN | 47586 |
| HICL Sequence Number | 046305 |
| HICL Sequence Number Description | TEPROTUMUMAB-TRBW |
| Brand/Generic | Brand |
| Proprietary Name | TEPEZZA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | teprotumumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | TEPROTUMUMAB |
| Labeler Name | Horizon Therapeutics USA, Inc. |
| Pharmaceutical Class | Insulin-like Growth Factor-1 Receptor Inhibitor [EPC], Insulin-like Growth Factor-1 Receptor Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761143 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75987-0130-15 (75987013015)
| NDC Package Code | 75987-130-15 |
|---|---|
| Billing NDC | 75987013015 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-01-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |