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United States · US · US:68788-8543_f9fe1ede-39bd-4d0c-99c3-86f612fa88b6
Amlodipine Besylate
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878885431100 TABLET in 1 BOTTLE, PLASTIC (68788-8543-1)
- ndc11687888543330 TABLET in 1 BOTTLE, PLASTIC (68788-8543-3)
- ndc11687888543660 TABLET in 1 BOTTLE, PLASTIC (68788-8543-6)
- ndc11687888543990 TABLET in 1 BOTTLE, PLASTIC (68788-8543-9)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A203245
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Benazepril Hydrochloride Capsule
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": {
"6efc0ef6-0424-44fc-a9ea-eb30c3b83239": {
"match": "brand_token",
"title": "AMLODIPINE BESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "68788-8543_f9fe1ede-39bd-4d0c-99c3-86f612fa88b6",
"productndc": "68788-8543",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203245",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Oct 21, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Oct 21, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Oct 21, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE",
"shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Amlodipine Besylate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203245",
"marketing_category": "ANDA",
"nonproprietary_name": "Amlodipine Besylate",
"start_marketing_date": "20231106",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C08CA01.
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