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United States · US · US:70247-018_48514b70-3b57-8897-e063-6294a90aa52f

Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerQingdao BAHEAL Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeA10BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7024701860
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70247-018-60)

Annotations

UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A209993
AB2AB2
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": {
    "1cb2b2be-595c-4e72-8d2c-c1edc7f85682": {
      "match": "brand_token",
      "title": "METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70247-018_48514b70-3b57-8897-e063-6294a90aa52f",
  "productndc": "70247-018",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Dec 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Dec 27, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride Extended-Release Tablets",
  "start_marketing_date": "20190301",
  "active_numerator_strength": "1000"
}

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