Label: PIROXICAM capsule
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NDC Code(s):
70771-1429-0,
70771-1429-1,
70771-1429-2,
70771-1429-3, view more70771-1429-4, 70771-1429-5, 70771-1429-9, 70771-1430-0, 70771-1430-1, 70771-1430-2, 70771-1430-3, 70771-1430-4, 70771-1430-5, 70771-1430-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 4, 2023
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INGREDIENTS AND APPEARANCE
PIROXICAM
piroxicam capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1429 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIROXICAM (UNII: 13T4O6VMAM) (PIROXICAM - UNII:13T4O6VMAM) PIROXICAM 10 mg Inactive Ingredients Ingredient Name Strength 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 Color GREEN (DARK GREEN-LIGHT GREEN) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code 742 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1429-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 2 NDC:70771-1429-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 3 NDC:70771-1429-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 4 NDC:70771-1429-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 5 NDC:70771-1429-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 6 NDC:70771-1429-4 10 in 1 CARTON 01/10/2019 6 NDC:70771-1429-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205585 01/10/2019 PIROXICAM
piroxicam capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1430 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIROXICAM (UNII: 13T4O6VMAM) (PIROXICAM - UNII:13T4O6VMAM) PIROXICAM 20 mg Inactive Ingredients Ingredient Name Strength 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 Color GREEN (DARK GREEN-DARK GREEN) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code 743 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1430-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 2 NDC:70771-1430-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 3 NDC:70771-1430-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 4 NDC:70771-1430-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 5 NDC:70771-1430-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/10/2019 6 NDC:70771-1430-4 10 in 1 CARTON 01/10/2019 6 NDC:70771-1430-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205585 01/10/2019 Labeler - Zydus Lifesciences Limited (918596198)
