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United States · US · US:62559-278_4bca2b49-cd1c-4645-99e7-511dd1b67da6
Nebivolol
In shortageOrange BookUNIISPLATC C07AB12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC07AB12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116255927805500 TABLET in 1 BOTTLE (62559-278-05)
- ndc11625592783030 TABLET in 1 BOTTLE (62559-278-30)
- ndc11625592789090 TABLET in 1 BOTTLE (62559-278-90)
Annotations
UNII (FDA Substance ID)
JGS34J7L9I
NEBIVOLOL HYDROCHLORIDE
RxCUI 236883
Orange Book
A203659
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Nebivolol Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "JGS34J7L9I",
"rxcui": "236883",
"inchikey": "JWEXHQAEWHKGCW-VCVZPGOSSA-N;JWEXHQAEWHKGCW-BIISKSHESA-N",
"display_name": "NEBIVOLOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3e9e1048-b5ea-4d6a-9363-3ee0d059e088": {
"match": "brand_token",
"title": "NEBIVOLOL TABLET [MAJOR PHARMACEUTICALS]",
"spl_version": "4",
"published_date": "2026-05-21"
}
},
"productid": "62559-278_4bca2b49-cd1c-4645-99e7-511dd1b67da6",
"productndc": "62559-278",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203659",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Apr 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Apr 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Apr 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "004",
"approval_date": "Apr 16, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NEBIVOLOL HYDROCHLORIDE",
"shortage_reason": "Nebivolol Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Nebivolol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203659",
"marketing_category": "ANDA",
"nonproprietary_name": "Nebivolol",
"start_marketing_date": "20210917",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C07AB12.
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