🇺🇸
United States · US · US:72888-120_4e76bf70-d160-7cdd-e063-6294a90a3b7f
LABETALOL HYDROCHLORIDE
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117288812001100 TABLET, FILM COATED in 1 BOTTLE (72888-120-01)
- ndc117288812005500 TABLET, FILM COATED in 1 BOTTLE (72888-120-05)
Annotations
UNII (FDA Substance ID)
1GEV3BAW9J
LABETALOL HYDROCHLORIDE
RxCUI 202693
Orange Book
A211953
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": "72888-120_4e76bf70-d160-7cdd-e063-6294a90a3b7f",
"productndc": "72888-120",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211953",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 18, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Aug 18, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Aug 18, 2021"
}
],
"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": "ANDA211953",
"marketing_category": "ANDA",
"nonproprietary_name": "Labetalol Hydrochloride",
"start_marketing_date": "20210818",
"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.