METADATE CD

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerAytu BioPharma, Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6965458030
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-580-30)

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": {
    "be59f8b4-7842-42cc-9559-bfa747f0baa5": {
      "match": "brand_token",
      "title": "METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AYTU BIOPHARMA, INC.]",
      "spl_version": "6",
      "published_date": "2025-11-19"
    }
  },
  "productid": "69654-580_43e0b75f-01c3-28cd-e063-6394a90a74a8",
  "productndc": "69654-580",
  "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": "METADATE CD",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021259",
  "marketing_category": "NDA",
  "nonproprietary_name": "methylphenidate hydrochloride",
  "start_marketing_date": "20240222",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code N06BA04.

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