Kitabis Pak (Page 5 of 5)

Principal Display Panel — Kitabis Pak

NDC: 24492-850-56

PARI

KitabisTM Pak

Tobramycin Inhalation Solution, USP

Store in Refrigerator

Includes One PARI LC PLUS Nebulizer Set

Rx only

carton label
(click image for full-size original)
KITABIS PAK tobramycin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24492-850
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tobramycin (Tobramycin) Tobramycin 300 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Sulfuric Acid
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24492-850-56 14 POUCH in 1 CARTON contains a POUCH
1 4 AMPULE in 1 POUCH This package is contained within the CARTON (24492-850-56) and contains a AMPULE
1 5 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (24492-850-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205433 02/19/2015
Labeler — Pari Respiratory Equipment, Inc. (804736098)
Establishment
Name Address ID/FEI Operations
Chongqing Daxin Pharmaceutical Co., Ltd. Shuitu Town Factory 421297606 API MANUFACTURE (24492-850)

Revised: 11/2019 Pari Respiratory Equipment, Inc.

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