FDA.reportPublic FDA data

ODACTRA 12 SQ-HDM Sublingual Tablet

RxCUI
1998631
RxNorm name
ODACTRA 12 SQ-HDM Sublingual Tablet
Display name
ODACTRA 12 SQ-HDM Sublingual Tablet
Full name
ODACTRA 12 SQ-HDM Sublingual Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125592OdactraHouse Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
71ca220d-78d5-47d4-be84-8d6e844b24b3ODACTRA 12 SQ-HDM Sublingual Tablet [PSN] · American house dust mite allergenic extract 6 SQ-HDM / European house dust mite allergenic extract 6 SQ-HDM Sublingual Tablet [Odactra] [SBD] · Dermatophagoides farinae extract 6 SQ-HDM / Dermatophagoides pteronyssinus extract 6 SQ-HDM Sublingual Tablet [Odactra] [SY] · ODACTRA 12 SQ-HDM Sublingual Tablet [SY]418These highlights do not include all the information needed to use ODACTRA safely and effectively. See full prescribing information for ODACTRA . ODACTRA ™ House Dust Mite ( Dermatophagoides farinae and Dermatophagoides pteronyssinus ) Allergen Extract Tablet for Sublingual U se Initial U.S. Approval: 201720250227