Labetalol Hydrochloride

Orange BookUNIISPLATC C07AG01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC07AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143918310
10 VIAL in 1 CARTON (0143-9183-10) / 4 mL in 1 VIAL (0143-9183-01)

Annotations

UNII (FDA Substance ID)

1GEV3BAW9J

LABETALOL HYDROCHLORIDE

RxCUI 202693

Orange Book

N213330

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": "INTRAVENOUS",
  "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": "0143-9183_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8",
  "productndc": "0143-9183",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213330",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG/200ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 9, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/100ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 9, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG/200ML (1MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 9, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG/300ML (1MG/ML)",
        "product_no": "004",
        "approval_date": "Nov 9, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/2ML (5MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 18, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/4ML (5MG/ML)",
        "product_no": "006",
        "approval_date": "Aug 19, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LABETALOL HYDROCHLORIDE",
  "proprietary_name": "Labetalol Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA213330",
  "marketing_category": "NDA",
  "nonproprietary_name": "Labetalol Hydrochloride",
  "start_marketing_date": "20250828",
  "active_numerator_strength": "5"
}

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