Belladonna and Opium
These highlights do not include all the information needed to use BELLADONNA and OPIUM Suppositories safely and effectively. See full prescribing information for BELLADONNA and OPIUM Suppositories. Initial U.S. Approval: 1938
Approved
Approval ID
098b48e8-caee-4101-8d8a-c2c63efc796b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATROPA BELLADONNA and OPIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8435
Product Classification
G
Generic Name
ATROPA BELLADONNA and OPIUM
Product Specifications
Route of AdministrationRECTAL
Effective DateMay 12, 2021
FDA Product Classification
INGREDIENTS (6)
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
ATROPA BELLADONNAActive
Quantity: 16.2 mg in 1 1
Code: WQZ3G9PF0H
Classification: ACTIB
OPIUMActive
Quantity: 30 mg in 1 1
Code: 37M3MZ001L
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT