Labetalol Hydrochloride

Orange BookUNIISPLATC C07AG01

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

Identification

ManufacturerMethod Pharmaceuticals, LLC

CountryUS (United States)

ATC codeC07AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5865760401
100 TABLET, FILM COATED in 1 BOTTLE (58657-604-01)
ndc11
5865760450
500 TABLET, FILM COATED in 1 BOTTLE (58657-604-50)

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": "58657-604_46b55541-52d5-7213-e063-6294a90affc4",
  "productndc": "58657-604",
  "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 Hydrochloride",
  "start_marketing_date": "20191122",
  "active_numerator_strength": "300"
}

Related drugs

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