Labetalol Hydrochloride

Orange BookUNIISPLATC C07AG01

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

Identification

ManufacturerBiocon Pharma Inc.

CountryUS (United States)

ATC codeC07AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7037706311
30 TABLET, FILM COATED in 1 BOTTLE (70377-063-11)
ndc11
7037706312
100 TABLET, FILM COATED in 1 BOTTLE (70377-063-12)
ndc11
7037706313
500 TABLET, FILM COATED in 1 BOTTLE (70377-063-13)

Annotations

UNII (FDA Substance ID)

1GEV3BAW9J

LABETALOL HYDROCHLORIDE

RxCUI 202693

Orange Book

A209603

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1GEV3BAW9J",
    "rxcui": "202693",
    "inchikey": "WQVZLXWQESQGIF-UHFFFAOYSA-N",
    "display_name": "LABETALOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d3ca153c-25b2-4506-91bd-bf9d6a4c01fe": {
      "match": "brand_token",
      "title": "LABETALOL HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "4",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70377-063_f285cda1-e518-405e-9362-292ae2e14954",
  "productndc": "70377-063",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209603",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jun 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Jun 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Oct 18, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LABETALOL HYDROCHLORIDE",
  "proprietary_name": "Labetalol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209603",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Labetalol Hydrochloride",
  "start_marketing_date": "20241202",
  "active_numerator_strength": "400"
}

Related drugs

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