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United States · US · US:55154-4747_ae113f45-ad3e-4bd8-9119-b68d305b9af9
Labetalol Hydrochloride
Orange BookUNIISPLATC C07AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeC07AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155154474755 CARTRIDGE in 1 BAG (55154-4747-5) / 4 mL in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
1GEV3BAW9J
LABETALOL HYDROCHLORIDE
RxCUI 202693
Orange Book
A075239
AP
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": "INTRAVENOUS",
"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": "55154-4747_ae113f45-ad3e-4bd8-9119-b68d305b9af9",
"productndc": "55154-4747",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075239",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "5MG/ML",
"product_no": "001",
"approval_date": "Nov 29, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LABETALOL HYDROCHLORIDE",
"proprietary_name": "Labetalol Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075239",
"marketing_category": "ANDA",
"nonproprietary_name": "Labetalol Hydrochloride",
"start_marketing_date": "19991129",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AG01.
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