Pioglitazone and metformin hydrochloride

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeA10BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
3334217709
60 TABLET in 1 BOTTLE (33342-177-09)
ndc11
3334217711
100 TABLET in 1 BOTTLE (33342-177-11)
ndc11
3334217712
10 BLISTER PACK in 1 CARTON (33342-177-12) / 10 TABLET in 1 BLISTER PACK
ndc11
3334217744
1000 TABLET in 1 BOTTLE (33342-177-44)
ndc11
3334217757
180 TABLET in 1 BOTTLE (33342-177-57)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A204802

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": "33342-177_c05a0d40-cee7-4a54-90e5-acd59e23f8f3",
  "productndc": "33342-177",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204802",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Nov 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG;EQ 15MG BASE",
        "product_no": "002",
        "approval_date": "Nov 5, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "Pioglitazone and metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA204802",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pioglitazone and metformin hydrochloride",
  "start_marketing_date": "20151106",
  "active_numerator_strength": "850; 15"
}

Related drugs

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