Donnatal
Donnatal Tablets
Approved
Approval ID
54f28743-bb66-4234-8d20-8502a5ffdc26
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2013
Manufacturers
FDA
PBM Pharmaceuticals Inc.
DUNS: 785470050
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66213-425
Product Classification
G
Generic Name
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2013
FDA Product Classification
INGREDIENTS (9)
SCOPOLAMINE HYDROBROMIDEActive
Quantity: 0.0065 mg in 1 1
Code: 451IFR0GXB
Classification: ACTIB
ATROPINE SULFATEActive
Quantity: 0.0194 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
HYOSCYAMINE SULFATEActive
Quantity: 0.1037 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB