JORNAY PM

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerIronshore Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7137620203
100 CAPSULE in 1 BOTTLE (71376-202-03)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

N209311

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylphenidate Hydrochloride Tablet, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "4B3SC438HI",
    "rxcui": "203188",
    "inchikey": "JUMYIBMBTDDLNG-OJERSXHUSA-N;JUMYIBMBTDDLNG-QNTKWALQSA-N",
    "display_name": "METHYLPHENIDATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d95dede0-b1ff-4489-8f91-3bbe122852bf": {
      "match": "brand_token",
      "title": "JORNAY PM EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [IRONSHORE PHARMACEUTICALS INC.]",
      "spl_version": "16",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71376-202_1c0e3d41-30b4-4815-8dbc-5466eaf56f8f",
  "productndc": "71376-202",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209311",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 8, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Aug 8, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Aug 8, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Aug 8, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Aug 8, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
  "shortage_reason": "Methylphenidate Hydrochloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "JORNAY PM",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209311",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methylphenidate Hydrochloride",
  "start_marketing_date": "20190601",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code N06BA04.

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