Depo-Provera
Depo-Provera medroxyprogesteroneacetate injectablesuspension, USP
Approved
Approval ID
2425f944-15d7-4b84-95a0-6538e843f130
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 12, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3348
Application NumberNDA012541
Product Classification
M
Marketing Category
C73594
G
Generic Name
medroxyprogesterone acetate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 4, 2011
FDA Product Classification
INGREDIENTS (5)
MEDROXYPROGESTERONE ACETATEActive
Quantity: 400 mg in 1 mL
Code: C2QI4IOI2G
Classification: ACTIM
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 20.3 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
SODIUM SULFATE ANHYDROUSInactive
Quantity: 11 mg in 1 mL
Code: 36KCS0R750
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT