Estradiol
Estradiol Tablets USP
Approved
Approval ID
8f8c5a0b-4d7b-a5cb-e053-2995a90a494e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2022
Manufacturers
FDA
PharmPak, Inc.
DUNS: 175493840
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ESTRADIOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54348-702
Application NumberANDA040197
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESTRADIOL
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ESTRADIOLActive
Quantity: 2 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB