NDC Code(s) : 16714-645-01, 16714-645-02, 16714-645-03, 16714-646-01, 16714-646-02, 16714-646-03, 16714-647-01, 16714-647-02, 16714-647-03
Packager : NorthStar RxLLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pioglitazone Pioglitazone TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-645
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE(UNII: JQT35NPK6C)
(PIOGLITAZONE - UNII:X4OV71U42S) 		PIOGLITAZONE15 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular flat face bevelled edge) Size 7 mm
Flavor Imprint Code ML86
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-645-0130 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
2NDC:16714-645-0290 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
3NDC:16714-645-03500 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202467 08/18/2022
Pioglitazone Pioglitazone TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-646
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE(UNII: JQT35NPK6C)
(PIOGLITAZONE - UNII:X4OV71U42S) 		PIOGLITAZONE30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular flat face bevelled edge) Size 8 mm
Flavor Imprint Code ML87
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-646-0130 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
2NDC:16714-646-0290 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
3NDC:16714-646-03500 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202467 08/18/2022
Pioglitazone Pioglitazone TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:16714-647
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE(UNII: JQT35NPK6C)
(PIOGLITAZONE - UNII:X4OV71U42S) 		PIOGLITAZONE45 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape ROUND (circular flat face bevelled edge) Size 10 mm
Flavor Imprint Code ML91
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16714-647-0130 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
2NDC:16714-647-0290 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
3NDC:16714-647-03500 in 1 BOTTLE Type 0: Not a Combination Product18/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202467 08/18/2022

LABELER - NorthStar RxLLC(830546433)

REGISTRANT - Macleods Pharmaceuticals Limited(862128535)

Establishment
Name Address ID/FEI Business Operations
Macleods Pharmaceuticals Limited 676369519 ANALYSIS(16714-645, 16714-646, 16714-647), LABEL(16714-645, 16714-646, 16714-647), MANUFACTURE(16714-645, 16714-646, 16714-647), PACK(16714-645, 16714-646, 16714-647)

PRINCIPAL DISPLAY PANEL

Pioglitazone Tablets USP

NDC 16714-645-01
15 mg

30 Tablets
Rx only  

pioglitazone-15mg-30s.jpg



Pioglitazone Tablets USP

NDC 16714-645-02
15mg

90 Tablets
Rx only  

pioglitazone-15mg-30s.jpg


Pioglitazone Tablets USP

NDC 16714-645-03
15mg

500 Tablets
Rx only   
pioglitazone-15mg-30s.jpg

Pioglitazone Tablets USP

NDC 16714-646-01
30mg

30 Tablets
Rx only

pioglitazone-15mg-30s.jpg

Pioglitazone Tablets USP 

NDC 16714-646-02
30 mg

90 Tablets
Rx only  

pioglitazone-15mg-30s.jpg

Pioglitazone Tablets USP

NDC 16714-646-03

30mg

500 Tablets
Rx only  

pioglitazone-15mg-30s.jpg

Pioglitazone Tablets USP

NDC 16714-647-01
45mg
30 Tablets
Rx only  

pioglitazone-15mg-30s.jpg

Pioglitazone Tablets USP

NDC 16714-647-02

45 mg

90 Tablets
Rx only 

pioglitazone-15mg-30s.jpg

Pioglitazone Tablets USP

NDC 16714-647-03
45 mg
Rx only  

500 Tablets


pioglitazone-15mg-30s.jpg