Labetalol Hydrochloride

Orange BookUNIISPLATC C07AG01

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

Identification

ManufacturerMarlex Pharmaceuticals Inc

CountryUS (United States)

ATC codeC07AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1013571201
100 TABLET, FILM COATED in 1 BOTTLE (10135-712-01)
ndc11
1013571205
500 TABLET, FILM COATED in 1 BOTTLE (10135-712-05)

Annotations

UNII (FDA Substance ID)

R5H8897N95

LABETALOL

RxCUI 6185

Orange Book

A075215

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R5H8897N95",
    "rxcui": "6185",
    "inchikey": "SGUAFYQXFOLMHL-UHFFFAOYSA-N",
    "display_name": "LABETALOL",
    "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": "10135-712_23e98950-6176-fa93-e063-6294a90a60a9",
  "productndc": "10135-712",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075215",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 29, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jul 29, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Jul 29, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LABETALOL",
  "proprietary_name": "Labetalol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075215",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Labetalol",
  "start_marketing_date": "20201001",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code C07AG01.

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