FDA.reportPublic FDA data

OMLYCLO

Product NDC
72606-035
11-digit product format
726060035
Labeler code
72606
Product ID
72606-035_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
75 mg/.5mL
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
IngredientStrength
OMALIZUMAB75 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2P471X1Z11Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2726001Internal RxNorm lookup
2726008Internal RxNorm lookup
2726010Internal RxNorm lookup
2726011Internal RxNorm lookup
2735283Internal RxNorm lookup
2751593Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbd8709f-1636-45d9-ba94-5a3bc5f22f84Available on FDA.report

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMLYCLOOMALIZUMAB-IGECCELLTRION USA, Inc.dbd8709f-1636-45d9-ba94-5a3bc5f22f842026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761399
ndc (product): 72606-035

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761399Omlycloomalizumab-igec351(k) InterchangeableRx2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
72606-035-01726060035011 SYRINGE, GLASS in 1 CARTON (72606-035-01) / .5 mL in 1 SYRINGE, GLASS2026-09-010Current