Home NDC 69800-0250-1 ASCENIV
Product NDC 69800-0250
Requested package NDC 69800-0250-1
11-digit product format 698000250
Labeler code 69800
Product ID 69800-0250_4ecc6123-99fa-fa43-e063-6294a90a548f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HUMAN IMMUNOGLOBULIN G
Dosage form LIQUID
Route INTRAVENOUS
Labeler ADMA Biologics, Inc.
Application BLA125590
Marketing category BLA
Marketing start 2019-04-01
Substance HUMAN IMMUNOGLOBULIN G
Active strength 5 g/50mL
Pharmacologic classes Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ASCENIV
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN IMMUNOGLOBULIN G 5 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 66Y330CJHS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2123037 Internal RxNorm lookup 2123042 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 69800-0250-1 ASCENIV 1 in 1 CARTON LIQUID 1 12 69800-0250-2 ASCENIV 50 mL in 1 VIAL, SINGLE-USE LIQUID 50 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69800-0250 ASCENIV (HUMAN IMMUNOGLOBULIN G) LIQUID [ADMA BIOLOGICS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250507_d74f4360-3b51-496c-96fb-84c3976958d2.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125590 Asceniv Immune Globulin Intravenous, Human-slra 351(a) Rx 2026-06-01
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 69800-0250-1 69800025001 1 VIAL, SINGLE-USE in 1 CARTON (69800-0250-1) / 50 mL in 1 VIAL, SINGLE-USE (69800-0250-2) 2019-04-01 0000-00-00 No No Current