Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6516217803
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03)
ndc11
6516217809
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09)
ndc11
6516217810
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10)
ndc11
6516217811
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11)
ndc11
6516217850
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50)
ndc11
6516217889
10000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A078596

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": "65162-178_984302ad-793e-4f35-92da-e5e7f92154f6",
  "productndc": "65162-178",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078596",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 3, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Jan 3, 2008"
      }
    ],
    "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": "ANDA078596",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20091202",
  "active_numerator_strength": "500"
}

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