Levonorgestrel
These highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use.Initial U.S. Approval: 1982
Approved
Approval ID
d0bbb668-cc24-436b-9144-673a28b81f7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2013
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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 Code40032-620
Application NumberANDA202508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2013
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEVONORGESTRELActive
Quantity: 1.5 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB