methylphenidate hydrochloride

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591386919
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3869-19)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

A208861

AB3AB3AB3AB3AB3AB3AB3

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylphenidate Film, 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": "0591-3869_1895894a-ed70-4f82-b512-6bc184ee806c",
  "productndc": "0591-3869",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208861",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Dec 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Dec 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "40MG",
        "product_no": "005",
        "approval_date": "Dec 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "50MG",
        "product_no": "006",
        "approval_date": "Dec 13, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "60MG",
        "product_no": "007",
        "approval_date": "Dec 13, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
  "shortage_reason": "Methylphenidate Film, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "methylphenidate hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208861",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methylphenidate hydrochloride",
  "start_marketing_date": "20200930",
  "active_numerator_strength": "20"
}

Related drugs

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