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United States · US · US:46708-459_3fb35d37-f05c-44ff-be96-076adaa6da32

Amlodipine and Valsartan

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4670845910
    100 TABLET, FILM COATED in 1 CARTON (46708-459-10)
  • ndc11
    4670845930
    30 TABLET, FILM COATED in 1 BOTTLE (46708-459-30)
  • ndc11
    4670845931
    100 TABLET, FILM COATED in 1 BOTTLE (46708-459-31)
  • ndc11
    4670845971
    500 TABLET, FILM COATED in 1 BOTTLE (46708-459-71)
  • ndc11
    4670845990
    90 TABLET, FILM COATED in 1 BOTTLE (46708-459-90)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A202713
ABABABAB
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": "46708-459_3fb35d37-f05c-44ff-be96-076adaa6da32",
  "productndc": "46708-459",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202713",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;160MG",
        "product_no": "001",
        "approval_date": "Apr 3, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;160MG",
        "product_no": "002",
        "approval_date": "Apr 3, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;320MG",
        "product_no": "003",
        "approval_date": "Apr 3, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;320MG",
        "product_no": "004",
        "approval_date": "Apr 3, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; VALSARTAN",
  "shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine and Valsartan",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202713",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine and Valsartan",
  "start_marketing_date": "20161201",
  "active_numerator_strength": "10; 160"
}

Related drugs

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