Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4257133401
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-01)
ndc11
4257133405
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-05)
ndc11
4257133460
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-60)
ndc11
4257133490
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-90)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A212448

AB3AB3

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": "42571-334_46836128-22ce-1c77-e063-6294a90a9768",
  "productndc": "42571-334",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212448",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Jan 10, 2023"
      }
    ],
    "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": "ANDA212448",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20230301",
  "active_numerator_strength": "1000"
}

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