medroxyprogesterone acetate
These highlights do not include all the information needed to use MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION safely and effectively. See full prescribing information for MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION. MEDROXYPROGESTERONE ACETATE injectable suspension, for intramuscular use Initial U.S. Approval: 1959
Approved
Approval ID
6457d70a-2f25-4935-8511-726d988f7a03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1467
Application NumberANDA215397
Product Classification
M
Marketing Category
C73584
G
Generic Name
medroxyprogesterone acetate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (9)
MEDROXYPROGESTERONE ACETATEActive
Quantity: 150 mg in 1 mL
Code: C2QI4IOI2G
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 28.9 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 2.41 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.150 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 1.37 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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 Code70121-1480
Application NumberANDA215397
Product Classification
M
Marketing Category
C73584
G
Generic Name
medroxyprogesterone acetate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (9)
MEDROXYPROGESTERONE ACETATEActive
Quantity: 150 mg in 1 mL
Code: C2QI4IOI2G
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 28.9 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 2.41 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1.37 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.150 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 10/12/2022