Medroxyprogesterone Acetate
These highlights do not include all the information needed to use Medroxyprogesterone acetate Contraceptive Injection safely and effectively. See full prescribing information for Medroxyprogesterone acetate Contraceptive Injection. MEDROXYPROGESTERONE ACETATE injectable suspension, for intramuscular use Initial U.S. Approval: 1959
Approved
Approval ID
e364a31e-8926-4bda-b00e-efb097bd3830
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
Amphastar Pharmaceuticals, Inc.
DUNS: 024736733
Products 2
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 Code0548-5711
Application NumberANDA077334
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone acetate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 16, 2019
FDA Product Classification
INGREDIENTS (9)
Medroxyprogesterone acetateActive
Quantity: 150 mg in 1 mL
Code: C2QI4IOI2G
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
Polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Medroxyprogesterone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0548-5410
Application NumberANDA077235
Product Classification
M
Marketing Category
C73584
G
Generic Name
Medroxyprogesterone acetate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 16, 2019
FDA Product Classification
INGREDIENTS (9)
Polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Medroxyprogesterone acetateActive
Quantity: 150 mg in 1 mL
Code: C2QI4IOI2G
Classification: ACTIB