Octreotide Acetate (Page 5 of 5)

Octreotide Acetate Injection 200 mcg/mL, 5 mL Multi Dose Vial Carton Text

NDC 0703-3333-01 Rx only

Octreotide

Acetate Injection

1000 mcg/5 mL

(200 mcg/mL)

STORE REFRIGERATED AT 2 ºC to 8 ºC (36 ºF to 46 ºF);
PROTECT FROM LIGHT.
AFTER INITIAL USE, DISCARDWITHIN 14 DAYS

For Subcutaneous Injection

5 mL Multiple Dose Vial

Package/Label Display Panel

image
(click image for full-size original)

Octreotide Acetate Injection 1000 mcg/mL, 5 mL Multi Dose Vial Carton Text

NDC 0703-3343-01 Rx only

Octreotide

Acetate Injection

5000 mcg/5 mL

(1000 mcg/mL)

STORE REFRIGERATED AT 2 ºC to 8 ºC (36 ºF to 46 ºF);
PROTECT FROM LIGHT.
AFTER INITIAL USE, DISCARDWITHIN 14 DAYS

For Subcutaneous Injection

5 mL Multiple Dose Vial

OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-3301
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 50 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
MANNITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-3301-04 25 VIAL, SINGLE-USE in 1 TRAY contains a VIAL, SINGLE-USE (0703-3301-01)
1 NDC:0703-3301-01 1 mL in 1 VIAL, SINGLE-USE This package is contained within the TRAY (0703-3301-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075957 11/14/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-3311
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
MANNITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-3311-04 25 VIAL, SINGLE-USE in 1 TRAY contains a VIAL, SINGLE-USE (0703-3311-01)
1 NDC:0703-3311-01 1 mL in 1 VIAL, SINGLE-USE This package is contained within the TRAY (0703-3311-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075957 11/14/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-3321
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 500 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
MANNITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-3321-04 25 VIAL, SINGLE-USE in 1 TRAY contains a VIAL, SINGLE-USE (0703-3321-01)
1 NDC:0703-3321-01 1 mL in 1 VIAL, SINGLE-USE This package is contained within the TRAY (0703-3321-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075957 11/14/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-3333
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 200 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
PHENOL
MANNITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-3333-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0703-3333-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075959 11/23/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-3343
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTREOTIDE ACETATE (OCTREOTIDE) OCTREOTIDE 1000 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
PHENOL
MANNITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0703-3343-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0703-3343-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075959 11/23/2005
Labeler — Teva Parenteral Medicines, Inc. (794362533)

Revised: 09/2021 Teva Parenteral Medicines, Inc.

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