Home NDC 73650-316 TZIELD
Product NDC 73650-316
11-digit product format 736500316
Labeler code 73650
Product ID 73650-316_a43c4966-e649-4105-b439-eea5232c94f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name teplizumab-mzwv
Dosage form INJECTION
Route INTRAVENOUS
Labeler Provention Bio, Inc.
Application BLA761183
Marketing category BLA
Marketing start 2022-11-17
Substance TEPLIZUMAB
Active strength 1 mg/mL
Pharmacologic classes CD3-directed Antibody Interactions [MoA], CD3-directed Antibody [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TZIELD
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEPLIZUMAB 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S4M959U2IJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2621885 Internal RxNorm lookup 2621891 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73650-316-01 TZIELD 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 6 73650-316-01 TZIELD 1 in 1 CARTON INJECTION 1 6 73650-316-10 TZIELD 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 6 73650-316-10 TZIELD 10 in 1 CARTON INJECTION 10 6 73650-316-14 TZIELD 14 in 1 CARTON INJECTION 14 6 73650-316-14 TZIELD 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73650-316 TZIELD (TEPLIZUMAB-MZWV) INJECTION [PROVENTION BIO, INC.] 5 Current NDC, Legacy NDC, 6 package rows 20250508_e8a39a5f-139c-4510-9777-71cbb00138fa.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TZIELD TEPLIZUMAB-MZWV Provention Bio, Inc. e8a39a5f-139c-4510-9777-71cbb00138fa 2026-08-14 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761183 ndc (product): 73650-316
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761183 Tzield teplizumab-mzwv 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73650-316-01 73650031601 1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2022-11-17 0000-00-00 No No Current 73650-316-10 73650031610 10 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-10) > 2 mL in 1 VIAL, SINGLE-DOSE 2022-11-17 0000-00-00 No No Current 73650-316-14 73650031614 14 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-14) > 2 mL in 1 VIAL, SINGLE-DOSE 2022-11-17 0000-00-00 No No Current