United States· US:59011-271_a4f435c1-f825-4252-b9e2-d3a04a674ff3

Hysingla ER

A hydrocodone product containing hydrocodone bitartrate, registered in United States by Knoa Pharma LLC. The same ATC class is registered in 3 of our 19 countries.

ATC R05DA03Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedHysingla ERATCR05DA03REGISTER NO.US:59011-271_a4f435c1…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Hydrocodone is registered in 3 of 19 countries.

Countries holding a registration under ATC R05DA03 (hydrocodone), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose

Hydrocodone · ATC R05DA03

3 / 19 countries

  • Canada
  • Norwayprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of hydrocodone costs, country by country.

Normalised to the WHO defined daily dose (15 mg), so markets compare like for like.

  • United States: $9.50 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown

Hydrocodone · price per daily dose (15 mg)

USD · FX 28 Sept 2026

  • US United States$9.50 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
hydrocodone bitartrate
Manufacturer
Knoa Pharma LLC
Country
United States (US)
ATC code
R05DA03
ATC class
Hydrocodone
Defined daily dose
15 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

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

Regulatory notes

UNII (FDA substance ID)
NO70W886KK
HYDROCODONE BITARTRATE
RxCUI 142439
Orange Book
N206627
ABABABABABAB
DailyMed SPL labels
1 version tracked

Interactions

593 interactions on record for hydrocodone.

Graded by severity as the source publishes them — 221 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Hydrocodone · interactions on record

593 records

  • 221 severe
  • 369 moderate

Most severe, free to view

  • ClotrimazoleA01AB18severe
  • CimetidineA02BA01severe
  • TriflupromazinA04AD06severe
  • AprepitantA04AD12severe

3 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Hydrocodone in 2 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All hydrocodone products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/fda54958-9b81-4e8d-a03b-33c6897a160b
GET /v1/drugs/fda54958-9b81-4e8d-a03b-33c6897a160b?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "NO70W886KK",
    "rxcui": "142439",
    "inchikey": "JMBRWJAVUIITGV-LNNMZZBZSA-N",
    "display_name": "HYDROCODONE BITARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "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"
}

See everything about hydrocodone.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.