Plan B One-Step
These highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step. Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
e17b3ec0-7739-4775-b7a2-a262f4f3a836
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
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 Code21695-973
Application NumberNDA021998
Product Classification
M
Marketing Category
C73594
G
Generic Name
levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2009
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LEVONORGESTRELActive
Quantity: 1.5 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB