Methylphenidate Hydrochloride

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5766460988
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-609-88)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

A205135

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": {
    "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": "57664-609_509cf8be-4306-9755-e063-6294a90ab425",
  "productndc": "57664-609",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "27MG",
        "product_no": "002",
        "approval_date": "Aug 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "36MG",
        "product_no": "003",
        "approval_date": "Aug 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "54MG",
        "product_no": "004",
        "approval_date": "Aug 19, 2020"
      }
    ],
    "appl_type": "A"
  },
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylphenidate Hydrochloride",
  "start_marketing_date": "20200820",
  "active_numerator_strength": "54"
}

Related drugs

Other records sharing ATC code N06BA04.

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