Pioglitazone HCL and Metformin HCL

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeA10BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
1366828005
500 TABLET in 1 BOTTLE (13668-280-05)
ndc11
1366828010
1000 TABLET in 1 BOTTLE (13668-280-10)
ndc11
1366828033
180 TABLET in 1 BOTTLE (13668-280-33)
ndc11
1366828060
60 TABLET in 1 BOTTLE (13668-280-60)
ndc11
1366828074
100 TABLET in 1 CARTON (13668-280-74)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A202001

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": "13668-280_d3ee8181-154a-4042-91e9-18b51ddc8994",
  "productndc": "13668-280",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202001",
    "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 HCL and Metformin HCL",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202001",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pioglitazone HCL and Metformin HCL",
  "start_marketing_date": "20250901",
  "active_numerator_strength": "500; 15"
}

Related drugs

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