CONCERTA

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5045858601
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-586-01)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

N021121

ABABABAB

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": {
    "1a88218c-5b18-4220-8f56-526de1a276cd": {
      "match": "brand_token",
      "title": "CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "30",
      "published_date": "2026-04-22"
    }
  },
  "productid": "50458-586_64d7c1e1-e7ed-4d74-a44d-13b4da64af9a",
  "productndc": "50458-586",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021121",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "18MG",
        "product_no": "001",
        "approval_date": "Aug 1, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "36MG",
        "product_no": "002",
        "approval_date": "Aug 1, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "54MG",
        "product_no": "003",
        "approval_date": "Dec 8, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "27MG",
        "product_no": "004",
        "approval_date": "Apr 1, 2002"
      }
    ],
    "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": "CONCERTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021121",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methylphenidate hydrochloride",
  "start_marketing_date": "20000801",
  "active_numerator_strength": "36"
}

Related drugs

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