Estradiol
ESTRADIOL TABLETS, USP
Approved
Approval ID
c674e1bc-5c8e-4c59-8de5-c7fa5306706d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-623
Application NumberANDA040114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2006
FDA Product Classification
INGREDIENTS (7)
ESTRADIOLActive
Quantity: 2 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-613
Application NumberANDA040114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2006
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ESTRADIOLActive
Quantity: 1 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT