NDC Code(s) : 16714-999-01
Packager : NorthStar RxLLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-999
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)28.90 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)2.41 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.68 mg in 1 mL
METHYLPARABEN(UNII: A2I8C7HI9T)1.37 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.15 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-999-011 in 1 CARTON 25/11/2019
11 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210761 11/25/2019

LABELER - NorthStar RxLLC(830546433)

REGISTRANT - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS(16714-999), MANUFACTURE(16714-999)

PRINCIPAL DISPLAY PANEL

NDC 16714-999-01
 Rx only
medroxyPROGESTERone Acetate Injectable Suspension, USP
150 mg/mL
For intramuscular use only
Single-dose Syringe
1 mL Prefilled Syringe
Northstar Rx

spl-medroxy-pfs-carton

PRINCIPAL DISPLAY PANEL

NDC 16714-999-01
Rx only
medroxyPROGESTERone Acetate Injectable Suspension, USP
150 mg/mL
 Intramuscular use only
 1 mL Single-dose Syringe
 Northstar Rx


spl-medroxy-pfs-label