🇺🇸
United States · US · US:51662-1602_ea035948-1a97-5d6e-e053-2995a90a3e7b
LABETALOL HCl
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1151662160211 VIAL in 1 BOX, UNIT-DOSE (51662-1602-1) / 20 mL in 1 VIAL
- ndc11516621602920 mL in 1 VIAL (51662-1602-9)
Annotations
UNII (FDA Substance ID)
1GEV3BAW9J
LABETALOL HYDROCHLORIDE
RxCUI 202693
Orange Book
A075303
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": "51662-1602_ea035948-1a97-5d6e-e053-2995a90a3e7b",
"productndc": "51662-1602",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "075303",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5MG/ML",
"product_no": "001",
"approval_date": "May 28, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LABETALOL HYDROCHLORIDE",
"proprietary_name": "LABETALOL HCl",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075303",
"marketing_category": "ANDA",
"nonproprietary_name": "LABETALOL HCl",
"start_marketing_date": "20220829",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AG01.
Access this data programmatically
Query LABETALOL HCl 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.