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United States · US · US:33342-516_366134cd-6244-45fc-99f1-0193a0221b3a
Labetalol Hydrochloride
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc113334251611100 TABLET, FILM COATED in 1 BOTTLE (33342-516-11)
- ndc113334251615500 TABLET, FILM COATED in 1 BOTTLE (33342-516-15)
Annotations
UNII (FDA Substance ID)
1GEV3BAW9J
LABETALOL HYDROCHLORIDE
RxCUI 202693
Orange Book
A217949
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": "33342-516_366134cd-6244-45fc-99f1-0193a0221b3a",
"productndc": "33342-516",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217949",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 23, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Sep 23, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Sep 23, 2025"
}
],
"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": "ANDA217949",
"marketing_category": "ANDA",
"nonproprietary_name": "Labetalol Hydrochloride",
"start_marketing_date": "20250923",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C07AG01.
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