Cotempla XR-ODT

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerNeos Therapeutics Brands, LLC

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7016520030
5 BLISTER PACK in 1 CARTON (70165-200-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

207ZZ9QZ49

METHYLPHENIDATE

RxCUI 6901

Orange Book

N205489

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": "ORAL",
  "spl_meta": {
    "33f70f58-c871-42c8-8adb-345caeafefcd": {
      "match": "brand_token",
      "title": "COTEMPLA XR-ODT (METHYLPHENIDATE) TABLET, ORALLY DISINTEGRATING [NEOS THERAPEUTICS BRANDS, LLC]",
      "spl_version": "15",
      "published_date": "2025-11-17"
    }
  },
  "productid": "70165-200_3f8e1342-96a7-1d02-e063-6394a90a3903",
  "productndc": "70165-200",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "205489",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8.6MG",
        "product_no": "001",
        "approval_date": "Jun 19, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "17.3MG",
        "product_no": "002",
        "approval_date": "Jun 19, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25.9MG",
        "product_no": "003",
        "approval_date": "Jun 19, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "34.6MG",
        "product_no": "004",
        "approval_date": "Aug 19, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPHENIDATE",
  "shortage_reason": "Methylphenidate Hydrochloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Cotempla XR-ODT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205489",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methylphenidate",
  "start_marketing_date": "20170620",
  "active_numerator_strength": "17.3"
}

Related drugs

Other records sharing ATC code N06BA04.

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