🇺🇸
United States · US · US:71335-2507_97992e54-4553-4e64-97f8-0d04b6ff3133
Amlodipine Besylate
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc1171335250707 TABLET in 1 BOTTLE (71335-2507-0)
- ndc11713352507130 TABLET in 1 BOTTLE (71335-2507-1)
- ndc11713352507290 TABLET in 1 BOTTLE (71335-2507-2)
- ndc11713352507360 TABLET in 1 BOTTLE (71335-2507-3)
- ndc117133525074120 TABLET in 1 BOTTLE (71335-2507-4)
- ndc117133525075100 TABLET in 1 BOTTLE (71335-2507-5)
- ndc117133525076800 TABLET in 1 BOTTLE (71335-2507-6)
- ndc1171335250771000 TABLET in 1 BOTTLE (71335-2507-7)
- ndc117133525078180 TABLET in 1 BOTTLE (71335-2507-8)
- ndc11713352507910 TABLET in 1 BOTTLE (71335-2507-9)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A078043
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": {
"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": "71335-2507_97992e54-4553-4e64-97f8-0d04b6ff3133",
"productndc": "71335-2507",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078043",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jul 12, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Jul 12, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Jul 12, 2007"
}
],
"appl_type": "A"
},
"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": "Amlodipine Besylate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078043",
"marketing_category": "ANDA",
"nonproprietary_name": "Amlodipine Besylate",
"start_marketing_date": "20180815",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C08CA01.
Access this data programmatically
Query Amlodipine Besylate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.