methylphenidate hydrochloride CD

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerLannett Company, Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0527458337
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4583-37)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

N021259

AB2AB2AB2AB2AB2AB2

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": {
    "f7a7ffd1-bc30-4db8-8391-dddf76acd639": {
      "match": "brand_token",
      "title": "METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0527-4583_f528b726-e29b-4f47-a917-1c5cec4db11d",
  "productndc": "0527-4583",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021259",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Apr 3, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jun 19, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 27, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Feb 19, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Feb 19, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "006",
        "approval_date": "Feb 19, 2006"
      }
    ],
    "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": "methylphenidate hydrochloride CD",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021259",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "methylphenidate hydrochloride",
  "start_marketing_date": "20060321",
  "active_numerator_strength": "50"
}

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