NDC Code(s) : 23155-345-32, 23155-345-42, 23155-345-33, 23155-345-43, 23155-345-31, 23155-345-41, 23155-345-44
Packager : Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

propofolpropofol INJECTION, EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-345
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPOFOL(UNII: YI7VU623SF)
(PROPOFOL - UNII:YI7VU623SF) 		PROPOFOL10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL(UNII: 241ATL177A)
GLYCERIN(UNII: PDC6A3C0OX)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM(UNII: 7FLD91C86K)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-345-4220 in 1 CARTON 10/12/2021
1NDC:23155-345-3250 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:23155-345-4310 in 1 CARTON 10/12/2021
2NDC:23155-345-33100 mL in 1 VIAL Type 0: Not a Combination Product
3NDC:23155-345-4110 in 1 CARTON 10/12/2021
3NDC:23155-345-3120 mL in 1 VIAL Type 0: Not a Combination Product
4NDC:23155-345-4420 in 1 CARTON 10/12/2021
4NDC:23155-345-3120 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 ANDA206408 10/12/2021

LABELER - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)

REGISTRANT - AVET LIFESCIENCES PRIVATE LIMITED(853181664)

Establishment
Name Address ID/FEI Business Operations
Emcure Pharmaceuticals Limited 675467924 ANALYSIS(23155-345), MANUFACTURE(23155-345), PACK(23155-345), LABEL(23155-345)

PRINCIPAL DISPLAY PANEL

NDC 23155-345-44

Propofol Injectable Emulsion, USP

200 mg/20 mL

(10 mg/mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

20 x 20 mL Vials for Single Patient Use Only

20 mL label

NDC 23155 - 345 - 31

Propofol Injectable Emulsion, USP

200 mg/20 mL

(10 mg/mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

20 mL Vial for Single Patient Use Only

20 mL label

NDC 23155-345-42

Propofol Injectable Emulsion, USP

500 mg/50 mL

(10 mg/mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

20 x 50 mL Vials for Single Patient Use Only

20 mL label

NDC 23155-345-32

Propofol Injectable Emulsion, USP

500 mg/50 mL

(10 mg/mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

50 mL Vial for Single Patient Use Only

20 mL label

NDC 23155-345-43

Propofol Injectable Emulsion, USP

1,000 mg/100 mL

(10 mg/mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

10 x 100 mL Vials for Single Patient Use Only

20 mL label

NDC 23155-345-33

Propofol Injectable Emulsion, USP

1,000 mg/100 mL

(10 mg/mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

100 mL Vial for Single Patient Use Only

20 mL label