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
8abfde83-0ee3-4642-89cf-1d5ff423da31
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2013
Manufacturers
FDA
Pharmacist Pharmaceutical, LLC
DUNS: 830838251
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 Code63704-009
Application NumberANDA202508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2013
FDA Product Classification
INGREDIENTS (6)
LEVONORGESTRELActive
Quantity: 1.5 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT