NDC Code(s) : 0641-6076-01, 0641-6076-10, 0641-6077-01, 0641-6077-10
Packager : West-ward Pharmaceutical Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neostigmine MethylsulfateNeostigmine Methylsulfate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6076
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOSTIGMINE METHYLSULFATE(UNII: 98IMH7M386)
(NEOSTIGMINE - UNII:3982TWQ96G) 		NEOSTIGMINE METHYLSULFATE0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN(UNII: A2I8C7HI9T)1.8 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.2 mg in 1 mL
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)0.2 mg in 1 mL
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6076-1010 in 1 CARTON
1NDC:0641-6076-0110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1973
Neostigmine MethylsulfateNeostigmine Methylsulfate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6077
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOSTIGMINE METHYLSULFATE(UNII: 98IMH7M386)
(NEOSTIGMINE - UNII:3982TWQ96G) 		NEOSTIGMINE METHYLSULFATE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN(UNII: A2I8C7HI9T)1.8 mg in 1 mL
PROPYLPARABEN(UNII: Z8IX2SC1OH)0.2 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-6077-1010 in 1 CARTON
1NDC:0641-6077-0110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1973

PRINCIPAL DISPLAY PANEL

Neostigmine Methylsulfate Injection, USP
1:2000 (5 mg/10 mL)
(0.5 mg/mL)
10 mL Multiple Dose Vial
NDC 0641-6076-01

Neostigmine Methylsulfate Injection, USP 1:2000 (5 mg/10 mL) (0.5 mg/mL) 10 mL Multiple Dose Vial

 

Neostigmine Methylsulfate Injection, USP
1:2000 (5 mg/10 mL)
(0.5 mg/mL)
10 x 10 mL Multiple Dose Vials
NDC 0641-6076-10

Neostigmine Methylsulfate Injection, USP 1:2000 (5 mg/10 mL) (0.5 mg/mL) 10 mL Multiple Dose Vial

PRINCIPAL DISPLAY PANEL

Neostigmine Methylsulfate Injection, USP
1:1000 (10 mg/10 mL)
(1 mg/mL)
10 mL Multiple Dose Vial
NDC 0641-6077-01

Neostigmine Methylsulfate Injection, USP 1:1000 (10 mg/10 mL) (1 mg/mL) 10 mL Multiple Dose Vial

Neostigmine Methylsulfate Injection, USP
1:1000 (10 mg/10 mL)
(1 mg/mL)
10 x 10 mL Multiple Dose Vials
NDC 0641-6077-10

Neostigmine Methylsulfate Injection, USP 1:1000 (10 mg/10 mL) (1 mg/mL) 10 mL Multiple Dose Vial