Metformin hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7161086753
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53)
ndc11
7161086760
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60)
ndc11
7161086770
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70)
ndc11
7161086780
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A207427

AB1AB

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": {
    "1cb2b2be-595c-4e72-8d2c-c1edc7f85682": {
      "match": "brand_token",
      "title": "METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71610-867_2bc26279-774d-c799-e063-6394a90aae86",
  "productndc": "71610-867",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207427",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Dec 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Dec 13, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207427",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin hydrochloride",
  "start_marketing_date": "20240611",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code A10BA02.

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