Baxdela (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 450 mg Tablet Blister Pack Carton

NDC 70842-101-02

PHARMACIST: Please
dispense with medication
guide provided.

Baxdela®
(delafloxacin) tablets

450 mg per tablet

Contains 20 Tablets (2 blister cards of 10 tablets each)

Rx Only

Melinta
THERAPEUTICS

The
Antibiotics Company

PRINCIPAL DISPLAY PANEL -- 450 mg Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 450 mg Tablet Bottle Carton

NDC 70842-101-01

Baxdela®
(delafloxacin) tablets

450 mg per tablet

Contains 20 Tablets

Rx Only

PHARMACIST: Please dispense
with medication guide provided.

Melinta
THERAPEUTICS

The
Antibiotics Company

PRINCIPAL DISPLAY PANEL -- 450 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mg Vial Carton

NDC 70842-102-03

Baxdela®
(delafloxacin) for injection

300 mg per single-dose vial

Must be reconstituted and further diluted.
For intravenous infusion only.

Contains 10 Vials Rx Only

PRINCIPAL DISPLAY PANEL -- 300 mg Vial Carton
(click image for full-size original)
BAXDELA delafloxacin meglumine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70842-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
delafloxacin meglumine (delafloxacin) delafloxacin 450 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE 417 mg
POVIDONE K30 34 mg
CROSPOVIDONE (35 .MU.M) 109 mg
SODIUM BICARBONATE 140 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 5.5 mg
ANHYDROUS CITRIC ACID 5.5 mg
MAGNESIUM STEARATE 10 mg
WATER
Product Characteristics
Color BROWN (light-brown) Score no score
Shape OVAL Size 21mm
Flavor Imprint Code RX3341
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70842-101-02 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70842-101-03)
1 NDC:70842-101-03 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70842-101-02)
2 NDC:70842-101-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 20 TABLET in 1 BOTTLE This package is contained within the CARTON (70842-101-01)
3 NDC:70842-101-05 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 2 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70842-101-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208610 06/19/2017
BAXDELA delafloxacin meglumine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70842-102
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
delafloxacin meglumine (delafloxacin) delafloxacin 300 mg in 10.5 mL
Inactive Ingredients
Ingredient Name Strength
MEGLUMINE 59 mg in 10.5 mL
BETADEX SULFOBUTYL ETHER SODIUM 2400 mg in 10.5 mL
EDETATE DISODIUM 3.4 mg in 10.5 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Product Characteristics
Color YELLOW (light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70842-102-03 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (70842-102-01)
1 NDC:70842-102-01 10.5 mL in 1 VIAL, GLASS This package is contained within the CARTON (70842-102-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208611 06/19/2017
Labeler — Melinta Therapeutics, LLC (079949853)

Revised: 02/2021 Melinta Therapeutics, LLC

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