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United States · US · US:62135-731_459bebab-b18b-58b4-e063-6294a90ad140

Glipizide and metformin hcl

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213573160
    60 TABLET, FILM COATED in 1 BOTTLE (62135-731-60)

Annotations

UNII (FDA Substance ID)
X7WDT95N5C
GLIPIZIDE
RxCUI 4821
Orange Book
A078728
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "X7WDT95N5C",
    "rxcui": "4821",
    "inchikey": "ZJJXGWJIGJFDTL-UHFFFAOYSA-N",
    "display_name": "GLIPIZIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9b405ff3-6ce5-460a-9406-db92e0e6ab1b": {
      "match": "brand_token",
      "title": "GLIPIZIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-05-25"
    }
  },
  "productid": "62135-731_459bebab-b18b-58b4-e063-6294a90ad140",
  "productndc": "62135-731",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078728",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;250MG",
        "product_no": "001",
        "approval_date": "Jun 23, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "002",
        "approval_date": "Jun 23, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "003",
        "approval_date": "Jun 23, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIPIZIDE; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Glipizide and metformin hcl",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA078728",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glipizide and metformin hcl",
  "start_marketing_date": "20100629",
  "active_numerator_strength": "2.5; 250"
}

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