Metformin

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7051843700
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4370-0)
ndc11
7051843701
100 POUCH in 1 BOX (70518-4370-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4370-2)
ndc11
7051843703
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-3)
ndc11
7051843704
180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-4)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A209313

AB1AB

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": "70518-4370_3cf39c3e-e7c6-c6d6-e063-6294a90aede4",
  "productndc": "70518-4370",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209313",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Mar 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209313",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin ER 500 mg",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "500"
}

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