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United States · US · US:0078-0370_8f4647d0-4965-4dee-8f60-1340ef9be3de

Ritalin

In shortageOrange BookUNIISPLATC N06BA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeN06BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078037005
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0370-05)

Annotations

UNII (FDA Substance ID)
4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE
RxCUI 203188
Orange Book
N021284
AB1AB1AB1AB1
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": {
    "effd952d-ac94-47bb-b107-589a4934dcca": {
      "match": "brand_token",
      "title": "RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "36",
      "published_date": "2025-10-01"
    }
  },
  "productid": "0078-0370_8f4647d0-4965-4dee-8f60-1340ef9be3de",
  "productndc": "0078-0370",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021284",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jun 5, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jun 5, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Jun 5, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Apr 10, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Oct 27, 2014"
      }
    ],
    "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": "Ritalin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021284",
  "marketing_category": "NDA",
  "nonproprietary_name": "methylphenidate hydrochloride",
  "start_marketing_date": "20020605",
  "active_numerator_strength": "20"
}

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