Medroxyprogesterone Acetate
Approved
Approval ID
419479ee-c1e1-306c-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
Products 1
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 Code67296-0396
Application NumberANDA040159
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MEDROXYPROGESTERONE ACETATEActive
Quantity: 10 mg in 1 1
Code: C2QI4IOI2G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT