Prescription Drug Information: Pioglitazone Hydrochloride and Metformin Hydrochloride (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 15 mg/500 mg (60 Tablet Bottle)

Rising ® NDC 57237-217-60

Pioglitazone
and Metformin
Hydrochloride
Tablets, USP
15 mg*/500 mg
PHARMACIST: Dispense the Medication
Guide
provided separately to each patient.

60 Tablets Rx onlly

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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 15 mg/850 mg (60 Tablet Bottle)

Rising® NDC 65862-526-60

Pioglitazone
and Metformin
Hydrochloride
Tablets, USP
15 mg*/850 mg
PHARMACIST: Dispense the Medication
Guide provided separately to each patient

60 Tablets Rx only

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PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE pioglitazone hydrochloride and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-217
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE 15 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE (Oblong, Biconvex) Size 15mm
Flavor Imprint Code H;92
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-217-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-217-81 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200823 02/13/2013
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE pioglitazone hydrochloride and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE 15 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 850 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE CALCIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE (Oblong, Biconvex) Size 19mm
Flavor Imprint Code H;93
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-218-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-218-81 180 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200823 02/13/2013
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (57237-217), ANALYSIS (57237-218), MANUFACTURE (57237-217), MANUFACTURE (57237-218)

Revised: 02/2020 Rising Health, LLC

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