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United States · US · US:58151-354_643fa1a0-53d9-4ce8-bc04-44285b006997
Norvasc
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115815135430300 TABLET in 1 BOTTLE (58151-354-30)
- ndc11581513547790 TABLET in 1 BOTTLE (58151-354-77)
- ndc115815135488100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-354-88) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
N019787
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet
Raw payload (JSON)
{
"unii": {
"unii": "864V2Q084H",
"rxcui": "104416",
"inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
"display_name": "AMLODIPINE BESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7367289c-b0b0-466a-83e2-558e2985c29f": {
"match": "brand_token",
"title": "NORVASC (AMLODIPINE BESYLATE) TABLET [VIATRIS SPECIALTY LLC]",
"spl_version": "10",
"published_date": "2025-12-10"
}
},
"productid": "58151-354_643fa1a0-53d9-4ce8-bc04-44285b006997",
"productndc": "58151-354",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "019787",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jul 31, 1992"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Jul 31, 1992"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Jul 31, 1992"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE",
"shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"shortage_status": "current",
"proprietary_name": "Norvasc",
"active_ingred_unit": "mg/1",
"application_number": "NDA019787",
"marketing_category": "NDA",
"nonproprietary_name": "amlodipine besylate",
"start_marketing_date": "20240924",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C08CA01.
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