Lovastatin
Lovastatin Tablet USP
Approved
Approval ID
d3620ebe-87e1-4a93-96cc-ff20ddbb30b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-106
Application NumberANDA075991
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2010
FDA Product Classification
INGREDIENTS (9)
LovastatinActive
Quantity: 10 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-028
Application NumberANDA075991
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2010
FDA Product Classification
INGREDIENTS (9)
LovastatinActive
Quantity: 20 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-025
Application NumberANDA075991
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2010
FDA Product Classification
INGREDIENTS (9)
LovastatinActive
Quantity: 40 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT