SAXAGLIPTIN

Orange BookUNIISPLATC A10BH03

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeA10BH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6846272705
500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05)
ndc11
6846272714
10 BLISTER PACK in 1 CARTON (68462-727-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6846272730
30 TABLET, FILM COATED in 1 BOTTLE (68462-727-30)
ndc11
6846272790
90 TABLET, FILM COATED in 1 BOTTLE (68462-727-90)

Annotations

UNII (FDA Substance ID)

Z8J84YIX6L

SAXAGLIPTIN HYDROCHLORIDE

RxCUI 1043560

Orange Book

A205994

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Z8J84YIX6L",
    "rxcui": "1043560",
    "inchikey": "TUAZNHHHYVBVBR-NHKADLRUSA-N",
    "display_name": "SAXAGLIPTIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "65884427-4dde-63bb-a23f-36a7779c0a6b": {
      "match": "brand_token",
      "title": "SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]",
      "spl_version": "7",
      "published_date": "2026-05-20"
    }
  },
  "productid": "68462-727_4d1a25c6-4ffc-4714-98a9-c4dcb2049d6d",
  "productndc": "68462-727",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205994",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 31, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SAXAGLIPTIN HYDROCHLORIDE",
  "proprietary_name": "SAXAGLIPTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205994",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SAXAGLIPTIN",
  "start_marketing_date": "20230731",
  "active_numerator_strength": "5"
}

Related drugs

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