Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerScieGen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5022844605
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-05)
ndc11
5022844630
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30)
ndc11
5022844690
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A213334

AB3AB3

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": "50228-446_2cd1dc49-0219-4df8-8865-96ac77e77334",
  "productndc": "50228-446",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213334",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Apr 16, 2021"
      }
    ],
    "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": "ANDA213334",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride Extended-Release Tablets",
  "start_marketing_date": "20210416",
  "active_numerator_strength": "1000"
}

Related drugs

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