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FDA Approval

Belladonna and Opium

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

January 11, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Belladonna(16.2 mg in 1 1)

Opium(30 mg in 1 1)

Registrants (1)

Bryant Ranch Prepack

DUNS Number

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Labeler

Bryant Ranch Prepack

Registrant

Bryant Ranch Prepack

DUNS Number

171714327

Products (1)

Belladonna and Opium

NDC Product Code

63629-8435

Route of Administration

RECTAL

Effective Date

May 12, 2021

Ingredients

POLYETHYLENE GLYCOL 1450Inactive

Code: OJ4Z5Z32L4Class: IACT

BelladonnaActive

Code: WQZ3G9PF0HClass: ACTIBQuantity: 16.2 mg in 1 1

OpiumActive

Code: 37M3MZ001LClass: ACTIBQuantity: 30 mg in 1 1

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

POLYSORBATE 60Inactive

Code: CAL22UVI4MClass: IACT

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