Octreotide Acetate (Page 5 of 5)

PRINCIPAL DISPLAY PANEL 5,000 mcg/5 mL (1,000 mcg/mL)

NDC 0641-6178 -01 Rx only
Octreotide
Acetate Injection
5,000 mcg per 5 mL
(1,000 mcg/mL)
For Subcutaneous or Intravenous Use 5 mL Multiple Dose Vial

5000 mcg per 5 mL
(click image for full-size original)

SERIALIZATION IMAGE

Layout 1

SERIALIZATION IMAGE

Layout 2

OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6174
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
LACTIC ACID, L- 3 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6174-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0641-6174-01)
1 NDC:0641-6174-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0641-6174-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076313 04/04/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6175
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
LACTIC ACID, L- 3 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6175-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0641-6175-01)
1 NDC:0641-6175-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0641-6175-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076313 04/04/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6176
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
LACTIC ACID, L- 3 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6176-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0641-6176-01)
1 NDC:0641-6176-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0641-6176-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076313 04/04/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6177
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
LACTIC ACID, L- 3 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM HYDROXIDE
WATER
PHENOL 5 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6177-01 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 (0641-6177-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076330 04/08/2005
OCTREOTIDE ACETATE octreotide acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6178
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
LACTIC ACID, L- 3 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
PHENOL 5 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6178-01 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 (0641-6178-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076330 04/08/2005
Labeler — Hikma Pharmaceuticals USA Inc. (946499746)

Revised: 07/2021 Hikma Pharmaceuticals USA Inc.

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