PIROXICAM - piroxicam capsule 
Zydus Lifesciences Limited

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PIROXICAM CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1429-3 in bottle of 30 capsules

Piroxicam Capsules, USP, 10 mg

Rx only

30 capsules

ZYDUS

label

NDC 70771-1430-3 in bottle of 30 capsules

Piroxicam Capsules, USP, 20 mg

Rx only

30 capsules

ZYDUS

label
PIROXICAM 
piroxicam capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1429
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIROXICAM (UNII: 13T4O6VMAM) (PIROXICAM - UNII:13T4O6VMAM) PIROXICAM10 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (DARK GREEN-LIGHT GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 742
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1429-330 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
2NDC:70771-1429-990 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
3NDC:70771-1429-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
4NDC:70771-1429-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
5NDC:70771-1429-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
6NDC:70771-1429-410 in 1 CARTON01/10/2019
6NDC:70771-1429-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20558501/10/2019
PIROXICAM 
piroxicam capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1430
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIROXICAM (UNII: 13T4O6VMAM) (PIROXICAM - UNII:13T4O6VMAM) PIROXICAM20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (DARK GREEN-DARK GREEN) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 743
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1430-330 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
2NDC:70771-1430-990 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
3NDC:70771-1430-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
4NDC:70771-1430-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
5NDC:70771-1430-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2019
6NDC:70771-1430-410 in 1 CARTON01/10/2019
6NDC:70771-1430-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20558501/10/2019
Labeler - Zydus Lifesciences Limited (918596198)

Revised: 11/2022
Document Id: 20672ba1-c8fb-44a7-9e2b-1068b4503416
Set id: 5e43b2f2-f3b7-4c07-b1c8-b04f4739d3d2
Version: 4
Effective Time: 20221105
 
Zydus Lifesciences Limited