METFORMIN HYDROCHLORIDE

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerPreferred Pharmaceuticals Inc

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6878840761
100 TABLET in 1 BOTTLE (68788-4076-1)
ndc11
6878840763
30 TABLET in 1 BOTTLE (68788-4076-3)
ndc11
6878840766
60 TABLET in 1 BOTTLE (68788-4076-6)
ndc11
6878840767
180 TABLET in 1 BOTTLE (68788-4076-7)
ndc11
6878840768
120 TABLET in 1 BOTTLE (68788-4076-8)
ndc11
6878840769
90 TABLET in 1 BOTTLE (68788-4076-9)

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": "68788-4076_dfac4d9c-2f20-417c-a1be-4f1c2738f351",
  "productndc": "68788-4076",
  "dosage_form": "TABLET",
  "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": "20260127",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A10BA02.

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