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Belladonna Alkaloids with Phenobartbital

BELLADONNAALKALOIDS WITHPHENOBARBITALTABLETSRx OnlyRev. 04/05

Approved
Approval ID

04bcee32-714d-4f7c-866d-7872b0808690

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 3, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Belladonna Alkaloids with Phenobartbital

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-890
Product Classification
G
Generic Name
Belladonna Alkaloids with Phenobartbital
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2010
FDA Product Classification

INGREDIENTS (9)

ATROPINE SULFATEActive
Quantity: 0.0194 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SCOPOLAMINE HYDROBROMIDEActive
Quantity: 0.0065 mg in 1 1
Code: 451IFR0GXB
Classification: ACTIB
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.1037 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB

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Belladonna Alkaloids with Phenobartbital - FDA Drug Approval Details