Amlodipine and Valsartan

Orange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGolden State Medical Supply, Inc.

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5140777430
30 TABLET in 1 BOTTLE, PLASTIC (51407-774-30)

Annotations

UNII (FDA Substance ID)

1J444QC288

AMLODIPINE

RxCUI 17767

Orange Book

A090011

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1J444QC288",
    "rxcui": "17767",
    "inchikey": "HTIQEAQVCYTUBX-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE",
    "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": "51407-774_4f9c77d6-c13d-7ccb-e063-6394a90ae49f",
  "productndc": "51407-774",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090011",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;160MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;160MG",
        "product_no": "002",
        "approval_date": "Mar 28, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;320MG",
        "product_no": "003",
        "approval_date": "Mar 28, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;320MG",
        "product_no": "004",
        "approval_date": "Mar 28, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE; VALSARTAN",
  "proprietary_name": "Amlodipine and Valsartan",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA090011",
  "marketing_category": "ANDA",
  "nonproprietary_name": "amlodipine and valsartan",
  "start_marketing_date": "20130328",
  "active_numerator_strength": "10; 320"
}

Related drugs

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