sotalol hydrochloride
Sotalol Hydrochloride Tablets USP
Approved
Approval ID
1436950d-a07f-43bb-811f-201f2991dbf6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5549
Application NumberANDA075366
Product Classification
M
Marketing Category
C73584
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2012
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4435
Application NumberANDA075366
Product Classification
M
Marketing Category
C73584
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2012
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5614
Application NumberANDA075366
Product Classification
M
Marketing Category
C73584
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2012
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT