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NDC 00310-4535-30 IMJUDO 300 mg/15mL Details
IMJUDO 300 mg/15mL
IMJUDO is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is TREMELIMUMAB.
Product Information
NDC | 00310-4535 |
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Product ID | 0310-4535_4c293d27-b307-4b99-8ab0-904cf3d0353b |
Associated GPIs | |
GCN Sequence Number | 083971 |
GCN Sequence Number Description | tremelimumab-actl VIAL 300MG/15ML INTRAVEN |
HIC3 | V3J |
HIC3 Description | CYTOTOXIC T-LYMPHOCYTE ANTIGEN(CTLA-4)RMC ANTIBODY |
GCN | 53048 |
HICL Sequence Number | 048415 |
HICL Sequence Number Description | TREMELIMUMAB-ACTL |
Brand/Generic | Brand |
Proprietary Name | IMJUDO |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | tremelimumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 300 |
Active Ingredient Units | mg/15mL |
Substance Name | TREMELIMUMAB |
Labeler Name | AstraZeneca Pharmaceuticals LP |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761289 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00310-4535-30 (00310453530)
NDC Package Code | 0310-4535-30 |
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Billing NDC | 00310453530 |
Package | 1 VIAL in 1 CARTON (0310-4535-30) / 15 mL in 1 VIAL |
Marketing Start Date | 2022-10-21 |
NDC Exclude Flag | N |
Pricing Information | N/A |