Labetalol Hydrochloride
LABETALOL HYDROCHLORIDE TABLETS USPRx only
Approved
Approval ID
167c5861-c51b-45b2-9973-8e02e6ffc041
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Labetalol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-6047
Application NumberANDA074787
Product Classification
M
Marketing Category
C73584
G
Generic Name
Labetalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2013
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Labetalol HydrochlorideActive
Quantity: 200 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT