🇺🇸
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
- ndc116584166101100 TABLET, FILM COATED in 1 BOTTLE (65841-661-01)
- ndc1165841661101000 TABLET, FILM COATED in 1 BOTTLE (65841-661-10)
- ndc11658416611690 TABLET, FILM COATED in 1 BOTTLE (65841-661-16)
- ndc11658416617710 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"
}Related drugs
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