Metformin ER 500 mg

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerGranules India Ltd

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6220749131
5000 TABLET in 1 POUCH (62207-491-31)
ndc11
6220749135
25000 TABLET in 1 CARTON (62207-491-35)
ndc11
6220749143
100 TABLET in 1 BOTTLE (62207-491-43)
ndc11
6220749147
500 TABLET in 1 BOTTLE (62207-491-47)
ndc11
6220749149
1000 TABLET in 1 BOTTLE (62207-491-49)
ndc11
6220749154
30 TABLET in 1 BOTTLE (62207-491-54)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A209313

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": "62207-491_4ce18ed1-a825-c596-e063-6394a90a7192",
  "productndc": "62207-491",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209313",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Mar 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin ER 500 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209313",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin ER 500 mg",
  "start_marketing_date": "20180628",
  "active_numerator_strength": "500"
}

Related drugs

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