METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerTIME CAP LABORATORIES, INC

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4948362401
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-624-01)
ndc11
4948362450
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-624-50)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A090295

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": "49483-624_4d845f5a-3ab1-b5ac-e063-6394a90a75d6",
  "productndc": "49483-624",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090295",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 29, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Apr 29, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20160512",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code A10BA02.

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