Labetalol hydrochloride

Orange BookUNIISPLATC C07AG01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeC07AG01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7120509530
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30)
ndc11
7120509560
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60)
ndc11
7120509590
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90)

Annotations

UNII (FDA Substance ID)

1GEV3BAW9J

LABETALOL HYDROCHLORIDE

RxCUI 202693

Orange Book

A075133

ABABAB

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": "71205-095_5179866d-f336-4e03-85b0-972fbedb6b9e",
  "productndc": "71205-095",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075133",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 3, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 3, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Aug 3, 1998"
      }
    ],
    "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": "ANDA075133",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Labetalol hydrochloride",
  "start_marketing_date": "19980803",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code C07AG01.

Access this data programmatically

Query Labetalol hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs