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United States · US · US:65841-661_62c55ebc-1883-4bfb-a772-2614c99a2fec

Glipizide and Metformin Hydrochloride

Orange BookUNIISPLATC A10BB

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA10BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6584166101
    100 TABLET, FILM COATED in 1 BOTTLE (65841-661-01)
  • ndc11
    6584166110
    1000 TABLET, FILM COATED in 1 BOTTLE (65841-661-10)
  • ndc11
    6584166116
    90 TABLET, FILM COATED in 1 BOTTLE (65841-661-16)
  • ndc11
    6584166177
    10 BLISTER PACK in 1 CARTON (65841-661-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-661-30)

Annotations

UNII (FDA Substance ID)
X7WDT95N5C
GLIPIZIDE
RxCUI 4821
Orange Book
A078905
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": "65841-661_62c55ebc-1883-4bfb-a772-2614c99a2fec",
  "productndc": "65841-661",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078905",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;250MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;500MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;500MG",
        "product_no": "003",
        "approval_date": "Jan 31, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLIPIZIDE; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Glipizide and Metformin Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA078905",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glipizide and Metformin Hydrochloride",
  "start_marketing_date": "20160505",
  "active_numerator_strength": "5; 500"
}

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