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United States · US · US:65862-526_1468f2ff-4355-402a-8c46-0b9272ae633e

Pioglitazone Hydrochloride and Metformin Hydrochloride

Orange BookUNIISPLATC A10BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA10BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6586252618
    180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18)
  • ndc11
    6586252660
    60 TABLET, FILM COATED in 1 BOTTLE (65862-526-60)

Annotations

UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A200823
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "786Z46389E",
    "rxcui": "235743",
    "inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
    "display_name": "METFORMIN 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": "65862-526_1468f2ff-4355-402a-8c46-0b9272ae633e",
  "productndc": "65862-526",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "200823",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Feb 13, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG;EQ 15MG BASE",
        "product_no": "002",
        "approval_date": "Feb 13, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA200823",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pioglitazone Hydrochloride and Metformin Hydrochloride",
  "start_marketing_date": "20130213",
  "active_numerator_strength": "850; 15"
}

Related drugs

Other records sharing ATC code A10BA.

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