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United States · US · US:64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f

Actoplus Met

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA10BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6476415818
    180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18)
  • ndc11
    6476415841
    4 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6476415860
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60)

Annotations

UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
N021842
AB
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": {
    "42e49120-6f3f-11db-9fe1-0800200c9a66": {
      "match": "brand_token",
      "title": "ACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "27",
      "published_date": "2025-04-07"
    }
  },
  "productid": "64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f",
  "productndc": "64764-158",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021842",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Aug 29, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "850MG;EQ 15MG BASE",
        "product_no": "002",
        "approval_date": "Aug 29, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE",
  "proprietary_name": "Actoplus Met",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021842",
  "marketing_category": "NDA",
  "nonproprietary_name": "pioglitazone and metformin hydrochloride",
  "start_marketing_date": "20050829",
  "active_numerator_strength": "850; 15"
}

Related drugs

Other records sharing ATC code A10BA.

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