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United States · US · US:50090-7156_600f7629-8912-496d-872b-753dcdea425a
Labetalol hydrochloride
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115009071560100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-0)
- ndc11500907156190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-7156-1)
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": "50090-7156_600f7629-8912-496d-872b-753dcdea425a",
"productndc": "50090-7156",
"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": "300"
}Related drugs
Other records sharing ATC code C07AG01.
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