Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
5965185601
100 TABLET, FILM COATED in 1 BOTTLE (59651-856-01)
ndc11
5965185605
500 TABLET, FILM COATED in 1 BOTTLE (59651-856-05)
ndc11
5965185622
2000 TABLET, FILM COATED in 1 BOTTLE (59651-856-22)
ndc11
5965185650
50 TABLET, FILM COATED in 1 BOTTLE (59651-856-50)
ndc11
5965185660
60 TABLET, FILM COATED in 1 BOTTLE (59651-856-60)
ndc11
5965185679
300 TABLET, FILM COATED in 1 BOTTLE (59651-856-79)
ndc11
5965185690
90 TABLET, FILM COATED in 1 BOTTLE (59651-856-90)
ndc11
5965185699
1000 TABLET, FILM COATED in 1 BOTTLE (59651-856-99)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A077095

ABABAB

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": "59651-856_0bfb57c0-6114-4734-a8d7-b78102e7f8eb",
  "productndc": "59651-856",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077095",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Jan 14, 2005"
      }
    ],
    "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": "ANDA077095",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20240329",
  "active_numerator_strength": "1000"
}

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