NDC Code(s) : 0143-9526-10, 0143-9525-10
Packager : Hikma Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9526
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I)
(DEXMEDETOMIDINE - UNII:67VB76HONO) 		DEXMEDETOMIDINE4 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9526-1010 in 1 CASE 30/01/2020
11 in 1 POUCH
150 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206407 01/30/2020
Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9525
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I)
(DEXMEDETOMIDINE - UNII:67VB76HONO) 		DEXMEDETOMIDINE4 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9525-1010 in 1 BAG 30/01/2020
11 in 1 POUCH
1100 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206407 01/30/2020

LABELER - Hikma Pharmaceuticals USA Inc.(001230762)

PRINCIPAL DISPLAY PANEL

NDC 0143-9526-01 Rx only

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

200 mcg/50 mL* (4 mcg/mL)

For Intravenous Infusion | Ready to Use - Do Not Dilute

Sterile, nonpyrogenic | Single-Dose Flexible Container

Do not remove unit from overwrap until ready to use

*Each mL contains 4 mcg dexmedetomidine provided as 4.72 mcg
dexmedetomidine HCl and 9 mg of sodium chloride in water for
injection. pH is 4.5 to 7.0. Do not add supplementary medication. Do
not use in series connections. Use only if solution is clear. Discard
unused portion. Do not use if overwrap has been previously opened or
damaged. After removing the overwrap, check for minute leaks by
squeezing container firmly. If leaks are found, discard unit as sterility
may be impaired. Usual Dosage: See package insert. Store at 20° to
25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not
freeze. Preservative-Free.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 200 mcg/50 mL Outer Wrap LabelDexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 200 mcg/50 mL Outer Wrap Label

PRINCIPAL DISPLAY PANEL

NDC 0143-9525-01 Rx only

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

400 mcg/100 mL* (4 mcg/mL)

For Intravenous Infusion | Ready to Use - Do Not Dilute

Sterile, nonpyrogenic | Single-Dose Flexible Container

Do not remove unit from overwrap until ready to use

*Each mL contains 4 mcg dexmedetomidine provided as 4.72 mcg
dexmedetomidine HCl and 9 mg of sodium chloride in water for
injection. pH is 4.5 to 7.0. Do not add supplementary medication. Do
not use in series connections. Use only if solution is clear. Discard
unused portion. Do not use if overwrap has been previously opened or
damaged. After removing the overwrap, check for minute leaks by
squeezing container firmly. If leaks are found, discard unit as sterility
may be impaired. Usual Dosage: See package insert. Store at 20° to
25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not
freeze. Preservative-Free.

]Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg/100 mL Outer Wrap Label

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg/100 mL Outer Wrap Label

PRINCIPAL DISPLAY PANEL

Serialization image from Portugal