Plan B
These highlights do not include all the information needed to use Plan B safely and effectively. See full prescribing information for Plan B. Plan B (levonorgestrel) tablets, 0.75mg, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
fffebd01-3815-425f-8293-1ad909d0d0ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4894
Application NumberNDA021045
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2012
FDA Product Classification
INGREDIENTS (8)
LEVONORGESTRELActive
Quantity: 0.75 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT