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United States · US · US:71335-2063_5b73d168-447e-407c-b98f-8347b6cfd9e7
Labetalol HCL
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11713352063130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2063-1)
- ndc11713352063290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2063-2)
- ndc11713352063360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2063-3)
Annotations
UNII (FDA Substance ID)
1GEV3BAW9J
LABETALOL HYDROCHLORIDE
RxCUI 202693
Orange Book
A200908
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": "71335-2063_5b73d168-447e-407c-b98f-8347b6cfd9e7",
"productndc": "71335-2063",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200908",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 10, 2012"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Jul 10, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Jul 10, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LABETALOL HYDROCHLORIDE",
"proprietary_name": "Labetalol HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200908",
"marketing_category": "ANDA",
"nonproprietary_name": "Labetalol Hydrochloride",
"start_marketing_date": "20120724",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C07AG01.
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