Methylphenidate

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378826093
30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH

Annotations

UNII (FDA Substance ID)

207ZZ9QZ49

METHYLPHENIDATE

RxCUI 6901

Orange Book

A206497

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylphenidate Hydrochloride Tablet, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "207ZZ9QZ49",
    "rxcui": "6901",
    "inchikey": "DUGOZIWVEXMGBE-STQMWFEESA-N;DUGOZIWVEXMGBE-CHWSQXEVSA-N",
    "display_name": "METHYLPHENIDATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "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": "0378-8260_c5b3220c-d8cc-42a7-a0e8-3cc1ccc3d535",
  "productndc": "0378-8260",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "206497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG/9HR (1.1MG/HR)",
        "product_no": "001",
        "approval_date": "Mar 14, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG/9HR (1.6MG/HR)",
        "product_no": "002",
        "approval_date": "Mar 14, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG/9HR (2.2MG/HR)",
        "product_no": "003",
        "approval_date": "Mar 14, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG/9HR (3.3MG/HR)",
        "product_no": "004",
        "approval_date": "Mar 14, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPHENIDATE",
  "shortage_reason": "Methylphenidate Hydrochloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Methylphenidate",
  "active_ingred_unit": "mg/h",
  "application_number": "ANDA206497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylphenidate",
  "start_marketing_date": "20220627",
  "active_numerator_strength": "1.1"
}

Related drugs

Other records sharing ATC code N06BA04.

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