NDC Code(s) : 70069-021-01, 70069-021-25
Packager : Somerset Therapeutics, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-021
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)24.75 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (Clear, colorless solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70069-021-2525 in 1 CARTON 19/04/2018
1NDC:70069-021-011 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 ANDA207442 04/19/2018

LABELER - Somerset Therapeutics, LLC(079947873)

REGISTRANT - Somerset Therapeutics, LLC(079947873)

Establishment
Name Address ID/FEI Business Operations
Somerset Therapeutics Limited 677236695 ANALYSIS(70069-021), LABEL(70069-021), PACK(70069-021), MANUFACTURE(70069-021)

Establishment
Name Address ID/FEI Business Operations
Maiva Pharma Private Limited 725656438 ANALYSIS(70069-021), LABEL(70069-021), MANUFACTURE(70069-021), PACK(70069-021)

PRINCIPAL DISPLAY PANEL

Container Label (Vial)

Container LabelContainer Label

Carton Label

Container LabelContainer Label