METFORMIN HYDROCHLORIDE

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerLaurus Labs Limited

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
4238597701
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-01)
ndc11
4238597705
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-05)
ndc11
4238597711
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-11)
ndc11
4238597718
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-18)
ndc11
4238597730
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-30)
ndc11
4238597772
15 BLISTER PACK in 1 CARTON (42385-977-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
4238597790
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-90)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A217631

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": "42385-977_6a8acfd4-a0e4-41e3-bdb9-c0ceebfa0ffc",
  "productndc": "42385-977",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217631",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Oct 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Oct 5, 2023"
      }
    ],
    "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": "ANDA217631",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METFORMIN HYDROCHLORIDE",
  "start_marketing_date": "20231006",
  "active_numerator_strength": "500"
}

Related drugs

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