RELEXXII

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerVertical Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6802509510
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-10)
ndc11
6802509530
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-30)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

N216117

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": {
    "22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d": {
      "match": "brand_token",
      "title": "RELEXXII (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]",
      "spl_version": "18",
      "published_date": "2025-09-29"
    }
  },
  "productid": "68025-095_86f477e9-07fc-466b-913e-1a4434c91df4",
  "productndc": "68025-095",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "216117",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18MG",
        "product_no": "001",
        "approval_date": "Jun 23, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "27MG",
        "product_no": "002",
        "approval_date": "Jun 23, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "36MG",
        "product_no": "003",
        "approval_date": "Jun 23, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "45MG",
        "product_no": "004",
        "approval_date": "Jun 23, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "54MG",
        "product_no": "005",
        "approval_date": "Jun 23, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "63MG",
        "product_no": "006",
        "approval_date": "Jun 23, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "72MG",
        "product_no": "007",
        "approval_date": "Jun 23, 2022"
      }
    ],
    "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": "RELEXXII",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216117",
  "marketing_category": "NDA",
  "nonproprietary_name": "methylphenidate hydrochloride",
  "start_marketing_date": "20220623",
  "active_numerator_strength": "18"
}

Related drugs

Other records sharing ATC code N06BA04.

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