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United States · US · US:33342-459_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e
Nebivolol
In shortageOrange BookUNIISPLATC C07AB12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC07AB12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333424590730 TABLET in 1 BOTTLE (33342-459-07)
- ndc11333424591090 TABLET in 1 BOTTLE (33342-459-10)
- ndc11333424592512 BLISTER PACK in 1 CARTON (33342-459-25) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
JGS34J7L9I
NEBIVOLOL HYDROCHLORIDE
RxCUI 236883
Orange Book
A212661
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": "33342-459_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e",
"productndc": "33342-459",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212661",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jan 28, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Jan 28, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Jan 28, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "004",
"approval_date": "Jan 28, 2025"
}
],
"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": "ANDA212661",
"marketing_category": "ANDA",
"nonproprietary_name": "Nebivolol",
"start_marketing_date": "20250129",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AB12.
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