Home NDC 59584-138-01 Candin
Product NDC 59584-138
Requested package NDC 59584-138-01
11-digit product format 595840138
Labeler code 59584
Product ID 59584-138_9a38c2d2-b61f-43c2-951f-64106889466c
Type STANDARDIZED ALLERGENIC
Nonproprietary name Candida albicans Skin Test Antigen
Dosage form INJECTION, SOLUTION
Route INTRADERMAL
Labeler Nielsen BioSciences, Inc.
Application BLA103257
Marketing category BLA
Marketing start 1995-12-01
Substance CANDIDA ALBICANS
Active strength 1 U/.1mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59584-138 59584-138-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Candin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANDIDA ALBICANS 1 U/.1mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59584-138-01 Candin 1 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 1 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CANDIDA ALBICANS ACTIVE INGREDIENT 4D7G21HDBC CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 CANDIDA ALBICANS ACTIVE MOIETY 4D7G21HDBC CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 ALBUMIN (HUMAN) INACTIVE INGREDIENT ZIF514RVZR CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 Phenol INACTIVE INGREDIENT 339NCG44TV CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 Sodium Bicarbonate INACTIVE INGREDIENT 8MDF5V39QO CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59584-138 CANDIN (CANDIDA ALBICANS SKIN TEST ANTIGEN) INJECTION, SOLUTION [NIELSEN BIOSCIENCES, INC.] 25 Current NDC, Legacy NDC, 1 package rows 20250116_4254e4c8-4a44-4766-8caf-61c65dc3267c.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103257 Candin Candida albicans Skin Test Antigen for Cellular Hypersensitivity 351(a) Rx 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59584-138-01 59584013801 1 mL in 1 VIAL, MULTI-DOSE (59584-138-01) 1 ml 1995-12-01 0000-00-00 No No Current