Glumetza

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerSantarus, Inc.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6801200450
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

N021748

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": {
    "fb832474-88d9-4e29-95cd-fbc446944cc4": {
      "match": "brand_token",
      "title": "GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]",
      "spl_version": "30",
      "published_date": "2025-11-21"
    }
  },
  "productid": "68012-004_41eb528d-e235-4563-833a-5cf36381d6db",
  "productndc": "68012-004",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021748",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jun 3, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Jun 3, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Glumetza",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021748",
  "marketing_category": "NDA",
  "nonproprietary_name": "metformin hydrochloride",
  "start_marketing_date": "20180320",
  "active_numerator_strength": "500"
}

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