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United States · US · US:63187-779_103cbde3-9398-44e5-b27e-c4c77a46e97a

Metformin hydrochloride

Orange BookUNIISPLATC A10BA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA10BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6318777930
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-30)
  • ndc11
    6318777960
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-60)
  • ndc11
    6318777978
    180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-78)
  • ndc11
    6318777990
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-779-90)

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": "63187-779_103cbde3-9398-44e5-b27e-c4c77a46e97a",
  "productndc": "63187-779",
  "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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