Trandate
TRANDATE (labetalol hydrochloride) Tablets
Approved
Approval ID
a4195473-51a9-40f1-8678-1478ebca2d84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2009
Manufacturers
FDA
Prometheus Laboratories Inc.
DUNS: 967000860
Products 3
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 Code65483-392
Application NumberNDA018716
Product Classification
M
Marketing Category
C73594
G
Generic Name
labetalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (6)
labetalol hydrochlorideActive
Quantity: 200 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
labetalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65483-391
Application NumberNDA018716
Product Classification
M
Marketing Category
C73594
G
Generic Name
labetalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (8)
labetalol hydrochlorideActive
Quantity: 100 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
labetalol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65483-393
Application NumberNDA018716
Product Classification
M
Marketing Category
C73594
G
Generic Name
labetalol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2009
FDA Product Classification
INGREDIENTS (7)
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
hypromellose 2208 (15000 mpa.s)Inactive
Code: Z78RG6M2N2
Classification: IACT
labetalol hydrochlorideActive
Quantity: 300 mg in 1 1
Code: 1GEV3BAW9J
Classification: ACTIB
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT