pioglitazone

Generic: pioglitazone

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pioglitazone
Generic Name pioglitazone
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pioglitazone hydrochloride 45 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-647
Product ID 16714-647_099c78c5-8f25-4dc6-a713-b934d0067438
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202467
Listing Expiration 2026-12-31
Marketing Start 2022-08-18

Pharmacologic Class

Classes
ppar alpha [cs] ppar gamma [cs] peroxisome proliferator receptor alpha agonist [epc] peroxisome proliferator receptor gamma agonist [epc] peroxisome proliferator-activated receptor activity [moa] thiazolidinedione [epc] thiazolidinediones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714647
Hyphenated Format 16714-647

Supplemental Identifiers

RxCUI
312440 312441 317573
UPC
0316714645032 0316714645018 0316714646039 0316714647012 0316714646022 0316714646015 0316714647029 0316714647036
UNII
JQT35NPK6C

Packaging Origin

Original Packager
true

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 (source: ndc)
Generic Name pioglitazone (source: ndc)
Application Number ANDA202467 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (16714-647-01)
  • 90 TABLET in 1 BOTTLE (16714-647-02)
  • 500 TABLET in 1 BOTTLE (16714-647-03)
source: ndc

Packages (3)

16714-647-01 30 TABLET in 1 BOTTLE (16714-647-01) 16714-647-02 90 TABLET in 1 BOTTLE (16714-647-02) 16714-647-03 500 TABLET in 1 BOTTLE (16714-647-03)

Ingredients (1)

pioglitazone hydrochloride (45 mg/1)

Linked Drug Pages (1)

Pioglitazone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "099c78c5-8f25-4dc6-a713-b934d0067438", "openfda": {"upc": ["0316714645032", "0316714645018", "0316714646039", "0316714647012", "0316714646022", "0316714646015", "0316714647029", "0316714647036"], "unii": ["JQT35NPK6C"], "rxcui": ["312440", "312441", "317573"], "spl_set_id": ["692e662a-3b31-42c3-a075-42abe44c74db"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (16714-647-01)", "package_ndc": "16714-647-01", "marketing_start_date": "20220818"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (16714-647-02)", "package_ndc": "16714-647-02", "marketing_start_date": "20220818"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16714-647-03)", "package_ndc": "16714-647-03", "marketing_start_date": "20220818"}], "brand_name": "Pioglitazone", "product_id": "16714-647_099c78c5-8f25-4dc6-a713-b934d0067438", "dosage_form": "TABLET", "pharm_class": ["PPAR alpha [CS]", "PPAR gamma [CS]", "Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator Receptor gamma Agonist [EPC]", "Peroxisome Proliferator-activated Receptor Activity [MoA]", "Thiazolidinedione [EPC]", "Thiazolidinediones [CS]"], "product_ndc": "16714-647", "generic_name": "Pioglitazone", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pioglitazone", "active_ingredients": [{"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "45 mg/1"}], "application_number": "ANDA202467", "marketing_category": "ANDA", "marketing_start_date": "20220818", "listing_expiration_date": "20261231"}