PostDay One-Step
PostDay One-Step
Approved
Approval ID
01c8c95c-6fbe-4068-915d-74418a6bb570
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 23, 2025
Manufacturers
FDA
Home Health Brands, LLC
DUNS: 119462541
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 Code85506-100
Application NumberANDA207044
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2025
FDA Product Classification
INGREDIENTS (7)
LEVONORGESTRELActive
Quantity: 1.5 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
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