Medroxyprogesterone Acetate
Medroxyprogesterone Acetate Tablets USP
Approved
Approval ID
fda3368b-4ce3-4972-885d-066858831ee0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Medroxyprogesterone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-609
Application NumberANDA040159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2014
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MEDROXYPROGESTERONE ACETATEActive
Quantity: 2.5 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Medroxyprogesterone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-740
Application NumberANDA040159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2014
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MEDROXYPROGESTERONE ACETATEActive
Quantity: 5 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Medroxyprogesterone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-534
Application NumberANDA040159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2014
FDA Product Classification
INGREDIENTS (7)
MEDROXYPROGESTERONE ACETATEActive
Quantity: 10 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT