Levonorgestrel
Drug Facts
Approved
Approval ID
ac13a073-a33a-45f7-8483-eecc9190195f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2017
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 Code40032-622
Application NumberANDA202508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2017
FDA Product Classification
INGREDIENTS (6)
LEVONORGESTRELActive
Quantity: 1.5 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT