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Levonorgestrel Tablets, 0.75 mg
Approved
Approval ID
eb0e7e5e-36c4-4478-9200-fdb9149979f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levonorgestrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-443
Application NumberANDA078666
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2009
FDA Product Classification
INGREDIENTS (7)
LEVONORGESTRELActive
Quantity: 0.75 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT