Metoprolol Tartrate
Approved
Approval ID
88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2010
Manufacturers
FDA
Aurolife Pharma LLC
DUNS: 829084461
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13107-064
Application NumberANDA077739
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2010
FDA Product Classification
INGREDIENTS (13)
SODIUM GLYCOLATEInactive
Code: B75E535IMI
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 100 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13107-063
Application NumberANDA077739
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2010
FDA Product Classification
INGREDIENTS (13)
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM GLYCOLATEInactive
Code: B75E535IMI
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
Metoprolol Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13107-062
Application NumberANDA077739
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2010
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 25 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM GLYCOLATEInactive
Code: B75E535IMI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT