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United States · US · US:71205-562_09678d2f-39cd-4821-bcac-3ecdc853f822

Metformin HCl

Orange BookUNIISPLATC A10BA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA10BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7120556200
    100 TABLET in 1 BOTTLE (71205-562-00)
  • ndc11
    7120556230
    30 TABLET in 1 BOTTLE (71205-562-30)
  • ndc11
    7120556260
    60 TABLET in 1 BOTTLE (71205-562-60)
  • ndc11
    7120556290
    90 TABLET in 1 BOTTLE (71205-562-90)

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": "71205-562_09678d2f-39cd-4821-bcac-3ecdc853f822",
  "productndc": "71205-562",
  "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": "20170206",
  "active_numerator_strength": "500"
}

Related drugs

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