🇺🇸
United States · US · US:0409-2339_7ba44762-b760-4a8f-adce-65bf78cc5d98
Labetalol Hydrochloride
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11040923393410 CARTON in 1 PACKAGE (0409-2339-34) / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE (0409-2339-24)
Annotations
UNII (FDA Substance ID)
1GEV3BAW9J
LABETALOL HYDROCHLORIDE
RxCUI 202693
Orange Book
A075239
AP
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": "0409-2339_7ba44762-b760-4a8f-adce-65bf78cc5d98",
"productndc": "0409-2339",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075239",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "5MG/ML",
"product_no": "001",
"approval_date": "Nov 29, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LABETALOL HYDROCHLORIDE",
"proprietary_name": "Labetalol Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075239",
"marketing_category": "ANDA",
"nonproprietary_name": "Labetalol Hydrochloride",
"start_marketing_date": "20051018",
"active_numerator_strength": "5"
}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.