Metformin HCl

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8042504351
30 TABLET in 1 BOTTLE (80425-0435-1)
ndc11
8042504352
60 TABLET in 1 BOTTLE (80425-0435-2)
ndc11
8042504353
90 TABLET in 1 BOTTLE (80425-0435-3)
ndc11
8042504354
108 TABLET in 1 BOTTLE (80425-0435-4)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A090564

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": "80425-0435_22cef642-e37b-a74f-e063-6394a90aef9d",
  "productndc": "80425-0435",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090564",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Apr 22, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090564",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin HCl",
  "start_marketing_date": "20240903",
  "active_numerator_strength": "1000"
}

Related drugs

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