BeC Racepinephrine
Approved
Approval ID
30e35101-fa7b-536f-e063-6394a90a6e53
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Blue Echo Care LLC
DUNS: 117048847
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Racepinephrine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73117-518
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Racepinephrine
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
RACEPINEPHRINE HYDROCHLORIDEActive
Quantity: 11.25 mg in 0.5 mL
Code: 336096P2WE
Classification: ACTIM