NDC Code(s) : 61570-047-01, 61570-047-50, 61570-047-10, 61570-048-20
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NEOSPORIN G.U.neomycin sulfate - polymyxin B sulfate IRRIGANT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-047
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE(UNII: 057Y626693)
(NEOMYCIN - UNII:I16QD7X297) 		NEOMYCIN40 mg in 1 mL
POLYMYXIN B SULFATE(UNII: 19371312D4)
(POLYMYXIN B - UNII:J2VZ07J96K) 		POLYMYXIN B200000 [iU] in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61570-047-5050 in 1 CARTON 28/06/1966
1NDC:61570-047-011 mL in 1 AMPULE Type 0: Not a Combination Product
2NDC:61570-047-1010 in 1 CARTON 28/06/1966
2NDC:61570-047-011 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA060707 06/28/1966
NEOSPORIN G.U.neomycin sulfate - polymyxin B sulfate IRRIGANT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-048
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE(UNII: 057Y626693)
(NEOMYCIN - UNII:I16QD7X297) 		NEOMYCIN40 mg in 1 mL
POLYMYXIN B SULFATE(UNII: 19371312D4)
(POLYMYXIN B - UNII:J2VZ07J96K) 		POLYMYXIN B200000 [iU] in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61570-048-201 in 1 CARTON 28/06/1966
120 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 ANDA060707 06/28/1966

PRINCIPAL DISPLAY PANEL

Pfizer

NEOSPORIN®
G.U. IRRIGANT
(neomycin
sulfate-polymyxin B sulfate
solution for irrigation) 1 mL
NOT FOR INJECTION
REFRIGERATE
Distributed by: Pfizer Inc.,
New York, NY 10017

LOT
EXP

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label

PRINCIPAL DISPLAY PANEL

Pfizer

NDC 61570-047-10
Contains 10 of NDC 61570-047-01

NEOSPORIN® G.U. IRRIGANT Sterile
(neomycin sulfate-polymyxin B sulfate
solution for irrigation)

1 mL

A concentrated sterile antibiotic solution to be diluted for urinary bladder irrigation.

NOT FOR INJECTION

Each mL contains: neomycin sulfate equivalent to 40 mg neomycin base, polymyxin B sulfate 200,000 units, and
Water for Injection qs. For indications, dosage, precautions, etc., see enclosed package insert.
Store at 2° to 8°C (36° to 46°F).

10 Ampuls

Rx only

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Carton

PRINCIPAL DISPLAY PANEL

Pfizer

NEOSPORIN® G.U. IRRIGANT Sterile

(neomycin
sulfate-polymyxin B sulfate
solution for irrigation)

20 mL

Multiple-Dose Vial
Rx only

PRINCIPAL DISPLAY PANEL - 20 mL Vial Label

PRINCIPAL DISPLAY PANEL

Pfizer

NDC 61570-048-20

NEOSPORIN®
G.U. IRRIGANT
Sterile

(neomycin
sulfate-polymyxin B
sulfate solution for
irrigation)

20 mL

NOT FOR INJECTION

A concentrated sterile antibiotic
solution to be diluted for urinary
bladder irrigation.

Multiple-Dose Vial

Rx only

PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton