METFORMIN HYDROCHLORIDE

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerGLENMARK PHARMACEUTICALS INC., USA

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6846252101
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-01)
ndc11
6846252105
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-05)
ndc11
6846252190
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-90)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A212969

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": "68462-521_75378e1b-a55d-48ee-9a0a-cd82d2fb78a0",
  "productndc": "68462-521",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212969",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Nov 25, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Nov 25, 2019"
      }
    ],
    "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": "ANDA212969",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metformin hydrochloride",
  "start_marketing_date": "20191125",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code A10BA02.

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