Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7120588300
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-00)
ndc11
7120588311
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-11)
ndc11
7120588330
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-30)
ndc11
7120588355
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-55)
ndc11
7120588360
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-60)
ndc11
7120588364
240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-64)
ndc11
7120588372
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-72)
ndc11
7120588378
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-78)
ndc11
7120588390
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-883-90)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A203769

ABABABABAB

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": "71205-883_27a10d92-3e03-4881-9b8f-7d0ee57cb744",
  "productndc": "71205-883",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203769",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Sep 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Sep 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Sep 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "625MG",
        "product_no": "004",
        "approval_date": "Feb 9, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "005",
        "approval_date": "Feb 9, 2026"
      }
    ],
    "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": "ANDA203769",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METFORMIN HYDROCHLORIDE",
  "start_marketing_date": "20171121",
  "active_numerator_strength": "850"
}

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