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 · 5

ndc11
6878888661
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-1)
ndc11
6878888663
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-3)
ndc11
6878888666
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-6)
ndc11
6878888668
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-8)
ndc11
6878888669
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-9)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A217631

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": "68788-8866_103080cb-6381-44f6-8a31-1fc81e7c890f",
  "productndc": "68788-8866",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217631",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Oct 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Oct 5, 2023"
      }
    ],
    "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": "ANDA217631",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METFORMIN HYDROCHLORIDE",
  "start_marketing_date": "20250423",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A10BA02.

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