Next Choice
These highlights do not include all the information needed to use Next Choice safely and effectively. See full prescribing information for Next Choice . Next Choice (levonorgestrel) Tablets, 0.75 mg, for oral use Initial U.S. Approval: 1982
Approved
Approval ID
5b1e51bd-4496-4f65-9f1d-40fb2ac5016c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-450
Application NumberANDA078665
Product Classification
M
Marketing Category
C73584
G
Generic Name
levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2012
FDA Product Classification
INGREDIENTS (7)
LEVONORGESTRELActive
Quantity: 0.75 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT