Home NDC 72606-054 OMLYCLO
Product NDC 72606-054
11-digit product format 726060054
Labeler code 72606
Product ID 72606-054_89c265ef-7a29-46f4-aaa1-88ab318e30b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omalizumab-igec
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler CELLTRION USA, Inc.
Application BLA761399
Marketing category BLA
Marketing start 2026-09-01
Substance OMALIZUMAB
Active strength 300 mg/2mL
Pharmacologic classes Anti-IgE [EPC]; Decreased IgE Activity [PE]; IgE-directed Antibody Interactions [MoA]
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base OMLYCLO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMALIZUMAB 300 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2P471X1Z11 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2726001 Internal RxNorm lookup 2726008 Internal RxNorm lookup 2726010 Internal RxNorm lookup 2726011 Internal RxNorm lookup 2735283 Internal RxNorm lookup 2751593 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 OMLYCLO OMALIZUMAB-IGEC CELLTRION USA, Inc. dbd8709f-1636-45d9-ba94-5a3bc5f22f84 2026-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761399 ndc (product): 72606-054
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761399 Omlyclo omalizumab-igec 351(k) Interchangeable Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 72606-054-01 72606005401 1 SYRINGE, GLASS in 1 CARTON (72606-054-01) / 2 mL in 1 SYRINGE, GLASS 2026-09-01 0 Current 72606-054-02 72606005402 2 SYRINGE, GLASS in 1 CARTON (72606-054-02) / 2 mL in 1 SYRINGE, GLASS 2026-09-01 0 Current