PIROXICAM (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42571-176-01
Piroxicam
Capsules USP
10 mg
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx Only
100 Capsules MICRO LABS

10 mg label
(click image for full-size original)

NDC 42571-177-01
Piroxicam
Capsules USP
20 mg
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx Only
100 Capsules MICRO LABS

20 mg label
(click image for full-size original)
PIROXICAM piroxicam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-176
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIROXICAM (PIROXICAM) PIROXICAM 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C RED NO. 3
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color red (maroon cap) , blue (blue body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PR;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-176-15 15 CAPSULE in 1 BOTTLE None
2 NDC:42571-176-01 100 CAPSULE in 1 BOTTLE None
3 NDC:42571-176-05 500 CAPSULE in 1 BOTTLE None
4 NDC:42571-176-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206152 03/01/2018
PIROXICAM piroxicam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-177
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIROXICAM (PIROXICAM) PIROXICAM 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C RED NO. 3
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color red (maroon cap and maroon body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code PR;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-177-15 15 CAPSULE in 1 BOTTLE None
2 NDC:42571-177-01 100 CAPSULE in 1 BOTTLE None
3 NDC:42571-177-05 500 CAPSULE in 1 BOTTLE None
4 NDC:42571-177-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206152 03/01/2018
Labeler — Micro Labs Limited (862174955)
Establishment
Name Address ID/FEI Operations
Micro Labs Limited 915793658 analysis (42571-176), analysis (42571-177), label (42571-176), label (42571-177), manufacture (42571-176), manufacture (42571-177), pack (42571-176), pack (42571-177)

Revised: 05/2021 Micro Labs Limited

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