NDC Code(s) : 67457-887-00, 67457-887-99, 67457-887-01
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Medroxyprogesterone AcetateMedroxyprogesterone Acetate INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-887
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDROXYPROGESTERONE ACETATE(UNII: C2QI4IOI2G)
(MEDROXYPROGESTERONE - UNII:HSU1C9YRES) 		MEDROXYPROGESTERONE ACETATE150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-887-991 in 1 CARTON 10/12/2018
1NDC:67457-887-001 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:67457-887-0125 in 1 CARTON 10/12/2018
2NDC:67457-887-001 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210227 10/12/2018

LABELER - Mylan Institutional LLC(790384502)

PRINCIPAL DISPLAY PANEL

NDC 67457-887-01

MedroxyPROGESTERone Acetate Injectable Suspension, USP

150 mg/mL

Contraceptive Injection

For Intramuscular Use Only

Rx only

Mylan

25 x 1 mL Single-Dose Vials

Carton 1

PRINCIPAL DISPLAY PANEL

NDC 67457-887-99

MedroxyPROGESTERone Acetate Injectable Suspension, USP

150 mg/mL

Contraceptive Injection

For Intramuscular Use Only

Rx only

Mylan

1 mL Single-Dose Vial

Carton

PRINCIPAL DISPLAY PANEL

NDC 67457-887-00

MedroxyPROGESTERone Acetate Injectable Suspension, USP

150 mg/mL

Contraceptive Injection

For Intramuscular Use Only

Rx only

Mylan

1 mL Single-Dose Vial

Vial