LABETALOL HYDROCHLORIDE
Approved
Approval ID
7b09b29d-095d-4bf3-b991-8123c14d7a00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-994
Application NumberANDA075133
Product Classification
M
Marketing Category
C73584
G
Generic Name
LABETALOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2011
FDA Product Classification
INGREDIENTS (14)
LABETALOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT