Home NDC 85551-125 Hydroxocobalamin
Product NDC 85551-125
11-digit product format 855510125
Labeler code 85551
Product ID 85551-125_51e3535b-dc11-abe8-e063-6394a90a0c61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxocobalamin
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Xseer Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-06-01
Substance HYDROXOCOBALAMIN
Active strength 1 mg/mL
Pharmacologic classes Antidote [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydroxocobalamin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXOCOBALAMIN 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q40X8H422O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317106 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85551-125-30 85551012530 30 mL in 1 VIAL, GLASS (85551-125-30) 30 ml 2026-06-01 No No Current