Metformin hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6807114192
20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2)
ndc11
6807114193
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3)
ndc11
6807114196
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6)
ndc11
6807114198
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8)
ndc11
6807114199
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-9)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A201991

AB1

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": "68071-1419_3f67ac3d-1505-3418-e063-6394a90a938f",
  "productndc": "68071-1419",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201991",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2012"
      }
    ],
    "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": "ANDA201991",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin hydrochloride",
  "start_marketing_date": "20130301",
  "active_numerator_strength": "500"
}

Related drugs

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