Hysingla ER

Orange BookUNIISPLATC R05DA03

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

Identification

ManufacturerKnoa Pharma LLC

CountryUS (United States)

ATC codeR05DA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5901127160
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60)

Annotations

UNII (FDA Substance ID)

NO70W886KK

HYDROCODONE BITARTRATE

RxCUI 142439

Orange Book

N206627

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "NO70W886KK",
    "rxcui": "142439",
    "inchikey": "JMBRWJAVUIITGV-LNNMZZBZSA-N",
    "display_name": "HYDROCODONE BITARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b7d23ac2-e776-9f62-3290-c64c2d6eb353": {
      "match": "brand_token",
      "title": "HYSINGLA ER (HYDROCODONE BITARTRATE) TABLET, EXTENDED RELEASE [KNOA PHARMA LLC]",
      "spl_version": "16",
      "published_date": "2026-05-13"
    }
  },
  "productid": "59011-271_a4f435c1-f825-4252-b9e2-d3a04a674ff3",
  "productndc": "59011-271",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206627",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Nov 20, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Nov 20, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Nov 20, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Nov 20, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Nov 20, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "006",
        "approval_date": "Nov 20, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "120MG",
        "product_no": "007",
        "approval_date": "Nov 20, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCODONE BITARTRATE",
  "proprietary_name": "Hysingla ER",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206627",
  "marketing_category": "NDA",
  "nonproprietary_name": "hydrocodone bitartrate",
  "start_marketing_date": "20150115",
  "active_numerator_strength": "20"
}

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