sotalol hydrochloride
Sotalol Hydrochloride Tablets USP
Approved
Approval ID
6383dc39-15a9-4260-8064-18a8c83004b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
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.
sotalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-397
Application NumberANDA075366
Product Classification
M
Marketing Category
C73584
G
Generic Name
sotalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2009
FDA Product Classification
INGREDIENTS (8)
SOTALOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT