Levonorgestrel

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 089153071

Effective Date

January 15, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levonorgestrel(0.75 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

68180-851

Application Number

ANDA091328

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 15, 2019

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: 5W7SIA7YZWClass: ACTIBQuantity: 0.75 mg in 1 1

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT