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United States · US · US:46287-035_63a6bb49-fb68-4351-be5f-a6b6e8f6b540

NORLIQVA

In shortageOrange BookUNIISPLATC C08CA01

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

Identification

ManufacturerCMP Pharma, Inc.
CountryUS (United States)
ATC codeC08CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4628703515
    150 mL in 1 BOTTLE (46287-035-15)

Annotations

UNII (FDA Substance ID)
1J444QC288
AMLODIPINE
RxCUI 17767
Orange Book
N214439
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet
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": {
    "614d974f-51c7-4b18-8171-39eb6e8d4c03": {
      "match": "brand_token",
      "title": "NORLIQVA (AMLODIPINE) SOLUTION [CMP PHARMA, INC.]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "46287-035_63a6bb49-fb68-4351-be5f-a6b6e8f6b540",
  "productndc": "46287-035",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214439",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Feb 24, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "NORLIQVA",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA214439",
  "marketing_category": "NDA",
  "nonproprietary_name": "amlodipine",
  "start_marketing_date": "20220415",
  "active_numerator_strength": "1"
}

Related drugs

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