NDC Code(s) : 67457-778-00, 67457-778-05, 67457-779-30
Packager : Mylan Institutional LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprim INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-778
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE(UNII: JE42381TNV)
(SULFAMETHOXAZOLE - UNII:JE42381TNV) 		SULFAMETHOXAZOLE80 mg in 1 mL
TRIMETHOPRIM(UNII: AN164J8Y0X)
(TRIMETHOPRIM - UNII:AN164J8Y0X) 		TRIMETHOPRIM16 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BENZYL ALCOHOL(UNII: LKG8494WBH)
DIETHANOLAMINE(UNII: AZE05TDV2V)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
NITROGEN(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-778-0510 in 1 CARTON 31/12/2017
1NDC:67457-778-005 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206607 12/31/2017
Sulfamethoxazole and Trimethoprimsulfamethoxazole and trimethoprim INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-779
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE(UNII: JE42381TNV)
(SULFAMETHOXAZOLE - UNII:JE42381TNV) 		SULFAMETHOXAZOLE80 mg in 1 mL
TRIMETHOPRIM(UNII: AN164J8Y0X)
(TRIMETHOPRIM - UNII:AN164J8Y0X) 		TRIMETHOPRIM16 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BENZYL ALCOHOL(UNII: LKG8494WBH)
DIETHANOLAMINE(UNII: AZE05TDV2V)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
NITROGEN(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67457-779-301 in 1 CARTON 31/12/2017
130 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206607 12/31/2017

LABELER - Mylan Institutional LLC(790384502)

REGISTRANT - Mylan Pharmaceuticals Inc(059295980)

Establishment
Name Address ID/FEI Business Operations
Mylan Laboratories Limited 677605290 MANUFACTURE(67457-778, 67457-779), ANALYSIS(67457-778, 67457-779), STERILIZE(67457-778, 67457-779), PACK(67457-778, 67457-779), LABEL(67457-778, 67457-779)

PRINCIPAL DISPLAY PANEL

NDC 67457-778-05

Sulfamethoxazole and Trimethoprim Injection, USP

Sulfamethoxazole 400 mg/5mL (80 mg/mL)

Trimethoprim 80 mg/5 mL (16 mg/mL)

For Intravenous Infusion Only

Must be diluted with 5% dextrose injection prior to administration

Sterile

Mylan

Rx only

10 x 5 mL Single-Dose Vials

Carton 5 mL

PRINCIPAL DISPLAY PANEL

NDC 67457-779-30

Sulfamethoxazole and Trimethoprim Injection, USP

Sulfamethoxazole 400 mg/5mL (80 mg/mL)

Trimethoprim 80 mg/5 mL (16 mg/mL)

For Intravenous Infusion Only

Must be diluted with 5% dextrose injection prior to administration

Sterile

Mylan

Rx only

30 mL Multiple-Dose Vials

Carton 30 mL