Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133525330
1000 TABLET, FILM COATED in 1 BOTTLE (71335-2533-0)
ndc11
7133525331
60 TABLET, FILM COATED in 1 BOTTLE (71335-2533-1)
ndc11
7133525332
100 TABLET, FILM COATED in 1 BOTTLE (71335-2533-2)
ndc11
7133525333
30 TABLET, FILM COATED in 1 BOTTLE (71335-2533-3)
ndc11
7133525334
120 TABLET, FILM COATED in 1 BOTTLE (71335-2533-4)
ndc11
7133525335
90 TABLET, FILM COATED in 1 BOTTLE (71335-2533-5)
ndc11
7133525336
28 TABLET, FILM COATED in 1 BOTTLE (71335-2533-6)
ndc11
7133525337
56 TABLET, FILM COATED in 1 BOTTLE (71335-2533-7)
ndc11
7133525338
180 TABLET, FILM COATED in 1 BOTTLE (71335-2533-8)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A209882

ABABAB

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": "71335-2533_e56912bc-7e1f-4c23-a23e-2c0e094c6b2c",
  "productndc": "71335-2533",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209882",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Aug 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Aug 27, 2018"
      }
    ],
    "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": "ANDA209882",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20210517",
  "active_numerator_strength": "1000"
}

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