Home NDC 0268-0248 histamine positive
Product NDC 0268-0248
11-digit product format 002680248
Labeler code 0268
Product ID 0268-0248_b405798b-4f02-4236-9b5d-00da85a2c6c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name histamine phosphate
Dosage form INJECTION, SOLUTION
Route INTRADERMAL
Labeler ALK-Abello, Inc.
Application BLA103754
Marketing category BLA
Marketing start 1989-10-23
Substance HISTAMINE PHOSPHATE
Active strength .275 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base histamine positive
Brand name suffix skin test control
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HISTAMINE PHOSPHATE .275 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QWB37T4WZZ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0268-0248-05 histamine positiveskin test control 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HISTAMINE PHOSPHATE ACTIVE INGREDIENT QWB37T4WZZ HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 1 HISTAMINE ACTIVE MOIETY 820484N8I3 HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-0248 HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) INJECTION, SOLUTION HISTAMINE POSITIVE SKIN TEST CONTROL (HISTAMINE PHOSPHATE) SOLUTION [ALK-ABELLO, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20200826_1159c24c-d9ce-49a2-b0bd-dc27c710f146.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 103754 Histatrol Positive Skin Test Control-Histamine 351(a) Rx 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0268-0248-05 00268024805 5 mL in 1 VIAL, MULTI-DOSE (0268-0248-05) 5 ml 1989-10-23 0000-00-00 No No Current