NDC Code(s) : 67877-678-69, 67877-678-70
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tobramycin Tobramycin SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-678
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN(UNII: VZ8RRZ51VK)
(TOBRAMYCIN - UNII:VZ8RRZ51VK) 		TOBRAMYCIN300 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-678-7056 in 1 CARTON 04/02/2021
1NDC:67877-678-697 in 1 POUCH
15 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 ANDA212848 04/02/2021

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Holopack Verpackungstechnik GmbH 343390324 MANUFACTURE(67877-678), PACK(67877-678)

PRINCIPAL DISPLAY PANEL

PRICIPAL DISPLAY PANEL- POUCH LABEL

NDC 6787-678-69
Tobramycin Inhalation Solution, USP
300 mg/5 ml Ampule
For Inhalation Only by Nebulizer
Contains no Preservatives
Contents: Each foil pouch seven sterile, non-pyrogenic, single-use ampules. Each 5 ml ampule
contains one 300 mg dose of Tobramycin USP and 11.25 mg Sodium Chloride in Sterile Water for injection.
Dosage and Administration: Each single-use ampule contains one 300 mg dose.
For inhalation only using required type of nebulizer. See package insert for full prescribing information.
Storage: store in refrigerator at5 2 to 8oC/36 to 46 oF. Protect from intense light .
See package insert for additional information.
Rx Only




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PRINCIPAL DISPLAY PANEL- CARTON LABEL

NDC 67877_678_70
Tobramycin Inhalation Solution, USP
300 mg/5 ml Ampule
56 Single-Dose 5 mL Ampules (28 Day Supply)




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PRINCIPAL DISPLAY PANEL- CONTAINER LABEL

Tobramycin Inhalation Solution, USp 300 mg/ 5 mL
Distributed: Ascend Laboratories,LLC
Lot No.XXXXX
B. No. XXXXX



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