pioglitazone hydrochloride and metformin hydrochloride

Generic: pioglitazone hydrochloride and metformin hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone hydrochloride and metformin hydrochloride
Generic Name pioglitazone hydrochloride and metformin hydrochloride
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1, pioglitazone hydrochloride 15 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-920
Product ID 42291-920_48bf9d36-1150-79d1-e063-6394a90aee09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200823
Listing Expiration 2027-12-31
Marketing Start 2023-03-13

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] peroxisome proliferator receptor alpha agonist [epc] peroxisome proliferator receptor gamma agonist [epc] peroxisome proliferator-activated receptor alpha agonists [moa] peroxisome proliferator-activated receptor gamma agonists [moa] thiazolidinedione [epc] thiazolidinediones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291920
Hyphenated Format 42291-920

Supplemental Identifiers

RxCUI
861783 861822
UPC
0342291921900
UNII
JQT35NPK6C 786Z46389E

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pioglitazone hydrochloride and metformin hydrochloride (source: ndc)
Generic Name pioglitazone hydrochloride and metformin hydrochloride (source: ndc)
Application Number ANDA200823 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (42291-920-90)
source: ndc

Packages (1)

42291-920-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-920-90)

Ingredients (2)

metformin hydrochloride (500 mg/1) pioglitazone hydrochloride (15 mg/1)

Linked Drug Pages (1)

Pioglitazone Hydrochloride and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48bf9d36-1150-79d1-e063-6394a90aee09", "openfda": {"upc": ["0342291921900"], "unii": ["JQT35NPK6C", "786Z46389E"], "rxcui": ["861783", "861822"], "spl_set_id": ["f6cd8da3-92cb-8800-e053-6394a90a3713"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42291-920-90)", "package_ndc": "42291-920-90", "marketing_start_date": "20230313"}], "brand_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride", "product_id": "42291-920_48bf9d36-1150-79d1-e063-6394a90aee09", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator Receptor gamma Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]", "Peroxisome Proliferator-activated Receptor gamma Agonists [MoA]", "Thiazolidinedione [EPC]", "Thiazolidinediones [CS]"], "product_ndc": "42291-920", "generic_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone Hydrochloride and Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA200823", "marketing_category": "ANDA", "marketing_start_date": "20230313", "listing_expiration_date": "20271231"}