Donnatal Extentabs
Donnatal Extentabs
Approved
Approval ID
2064014b-6f8e-4232-88c2-d1870042abc7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2011
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
NDC Product Code66213-421
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateOctober 17, 2011
Generic NamePhenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
INGREDIENTS (18)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM SULFATE, UNSPECIFIEDInactive
Code: WAT0DDB505
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PhenobarbitalActive
Quantity: 48.6 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
ATROPINE SULFATEActive
Quantity: 0.0582 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
SCOPOLAMINE HYDROBROMIDEActive
Quantity: 0.0195 mg in 1 1
Code: 451IFR0GXB
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL 2000Inactive
Code: HAF0412YIT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYOSCYAMINE SULFATEActive
Quantity: 0.3111 mg in 1 1
Code: F2R8V82B84
Classification: ACTIB