Amikacin Sulfate (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 0641-6166-01
Rx only
Amikacin
Sulfate Injection, USP
equivalent to amikacin
1 gram/4 mL
(250 mg/mL)
FOR IM OR IV USE
4 mL Vial
Each mL contains 250 mg amikacin (as
sulfate), 0.66% sodium metabisulfite,
2.5% sodium citrate dihydrate with pH
adjusted to 3.5 to 5.5 with sulfuric acid.
USUAL DOSAGE: 15 mg/kg/day divided
into 2 or 3 equal doses, IM. Do not
exceed 1.5 grams daily.
READ ENCLOSED INSERT for IV and
other uses.Store at 20º to 25ºC (68º to 77ºF).

NDC 0641-6166-01 Rx only Amikacin Sulfate Injection, USP equivalent to amikacin 1 gram/4 mL (250 mg/mL) FOR IM OR IV USE 4 mL Vial Each mL contains 250 mg amikacin (as sulfate), 0.66% sodium metabisulfite, 2.5% sodium citrate dihydrate with pH adjusted to 3.5 to 5.5 with sulfuric acid. USUAL DOSAGE: 15 mg/kg/day divided into 2 or 3 equal doses, IM. Do not exceed 1.5 grams daily. READ ENCLOSED INSERT for IV and other uses. Store at 20º to 25ºC (68º to 77ºF).
(click image for full-size original)

NDC 0641-6166-10
Rx only
Amikacin
Sulfate Injection, USP
equivalent to amikacin
1 gram/4 mL
(250 mg/mL)
For INTRAMUSCULAR or
INTRAVENOUS Use
10 x 4 mL Vials
Each mL contains 250 mg amikacin (as
sulfate), 0.66% sodium metabisulfite, 2.5%
sodium citrate dihydrate with pH adjusted to
3.5 to 5.5 with sulfuric acid.
USUAL DOSAGE: 15 mg/kg/day divided
into 2 or 3 equal doses, IM. Do not exceed
1.5 grams daily.
READ ENCLOSED INSERT for IV and other
uses.
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

NDC 0641-6166-10 Rx only Amikacin Sulfate Injection, USP equivalent to amikacin 1 gram/4 mL (250 mg/mL) For INTRAMUSCULAR or INTRAVENOUS Use 10 x 4 mL Vials Each mL contains 250 mg amikacin (as sulfate), 0.66% sodium metabisulfite, 2.5% sodium citrate dihydrate with pH adjusted to 3.5 to 5.5 with sulfuric acid. USUAL DOSAGE: 15 mg/kg/day divided into 2 or 3 equal doses, IM. Do not exceed 1.5 grams daily. READ ENCLOSED INSERT for IV and other uses. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
(click image for full-size original)
AMIKACIN SULFATE amikacin sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6166
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIKACIN SULFATE (AMIKACIN) AMIKACIN 250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE
SODIUM CITRATE
SULFURIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6166-10 10 VIAL in 1 CARTON contains a VIAL (0641-6166-01)
1 NDC:0641-6166-01 4 mL in 1 VIAL This package is contained within the CARTON (0641-6166-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063315 08/01/2015
AMIKACIN SULFATE amikacin sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6167
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIKACIN SULFATE (AMIKACIN) AMIKACIN 250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE
SODIUM CITRATE
SULFURIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6167-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0641-6167-01)
1 NDC:0641-6167-01 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0641-6167-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063315 08/01/2015
Labeler — West-Ward Pharmaceutical Corp. (946499746)
Establishment
Name Address ID/FEI Operations
West-ward Pharmaceutical Corp 946499746 ANALYSIS (0641-6166), ANALYSIS (0641-6167), LABEL (0641-6166), LABEL (0641-6167), MANUFACTURE (0641-6166), MANUFACTURE (0641-6167), PACK (0641-6166), PACK (0641-6167)

Revised: 07/2015 West-Ward Pharmaceutical Corp.

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