Donnatal
DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets Rx Only Revised: 02/20
Approved
Approval ID
c93cccdc-2f92-4cb3-9d14-06acdd51d94c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
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 Code59212-425
Product Classification
G
Generic Name
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (11)
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
ATROPINE SULFATEActive
Quantity: 0.0194 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SCOPOLAMINE HYDROBROMIDEActive
Quantity: 0.0065 mg in 1 1
Code: 451IFR0GXB
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.1037 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB