Lefluniclo (Page 8 of 8)

Lefluniclo Packaging

The packaging for Lefluniclo is shown below

Lefluniclo Packaging
(click image for full-size original)
LEFLUNICLO leflunomide and diclofenac sodium gel kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-602
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72835-602-02 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30
Part 2 1 TUBE 100 g
Part 1 of 2
LEFLUNOMIDE leflunomide tablet, film coated
Product Information
Item Code (Source) NDC:70748-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEFLUNOMIDE (LEFLUNOMIDE) LEFLUNOMIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code L;A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70748-130-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (70748-130-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211863 08/31/2020
Part 2 of 2
GOOD SENSE ARTHRITIS PAIN diclofenac sodium gel
Product Information
Item Code (Source) NDC:0113-1189
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
COCO-CAPRYLATE/CAPRATE
ISOPROPYL ALCOHOL
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0113-1189-01 100 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211253 08/22/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/11/2023
Labeler — V2 Pharma, LLC (102457346)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 manufacture (70748-130), pack (70748-130)
Establishment
Name Address ID/FEI Operations
L. Perrigo Company 006013346 label (0113-1189)
Establishment
Name Address ID/FEI Operations
V2 Pharma, LLC 102457346 label (72835-602)

Revised: 03/2023 V2 Pharma, LLC

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