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United States · US · US:71335-2057_234a948f-c052-44be-9400-caea7b33eb74
Labetalol Hydrochloride
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
- ndc11713352057130 TABLET, FILM COATED in 1 BOTTLE (71335-2057-1)
- ndc11713352057290 TABLET, FILM COATED in 1 BOTTLE (71335-2057-2)
- ndc11713352057360 TABLET, FILM COATED in 1 BOTTLE (71335-2057-3)
Annotations
UNII (FDA Substance ID)
R5H8897N95
LABETALOL
RxCUI 6185
Orange Book
A075215
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R5H8897N95",
"rxcui": "6185",
"inchikey": "SGUAFYQXFOLMHL-UHFFFAOYSA-N",
"display_name": "LABETALOL",
"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": "71335-2057_234a948f-c052-44be-9400-caea7b33eb74",
"productndc": "71335-2057",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075215",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 29, 1999"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "Jul 29, 1999"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Jul 29, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LABETALOL",
"proprietary_name": "Labetalol Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075215",
"marketing_category": "ANDA",
"nonproprietary_name": "Labetalol Hydrochloride",
"start_marketing_date": "20191122",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C07AG01.
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