PIOGLITAZONE HYDROCHLORIDE

Orange BookUNIISPLATC A10BG03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA10BG03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586251305
500 TABLET in 1 BOTTLE (65862-513-05)
ndc11
6586251310
3 BLISTER PACK in 1 CARTON (65862-513-10) / 10 TABLET in 1 BLISTER PACK
ndc11
6586251330
30 TABLET in 1 BOTTLE (65862-513-30)
ndc11
6586251390
90 TABLET in 1 BOTTLE (65862-513-90)

Annotations

UNII (FDA Substance ID)

JQT35NPK6C

PIOGLITAZONE HYDROCHLORIDE

RxCUI 259319

Orange Book

A200268

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JQT35NPK6C",
    "rxcui": "259319",
    "inchikey": "GHUUBYQTCDQWRA-UHFFFAOYSA-N",
    "display_name": "PIOGLITAZONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6cd7c8b7-f5d4-423b-ae9f-86541869d8cf": {
      "match": "brand_token",
      "title": "PIOGLITAZONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "5",
      "published_date": "2026-03-26"
    }
  },
  "productid": "65862-513_75b48749-1268-4752-8a50-83382f05c951",
  "productndc": "65862-513",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "200268",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Feb 13, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "002",
        "approval_date": "Feb 13, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 45MG BASE",
        "product_no": "003",
        "approval_date": "Feb 13, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "PIOGLITAZONE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200268",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pioglitazone hydrochloride",
  "start_marketing_date": "20130213",
  "active_numerator_strength": "30"
}

Related drugs

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