DEXMETHYLPHENIDATE HYDROCHLORIDE

Orange BookUNIISPLATC N06BA11

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

Identification

ManufacturerGranules Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06BA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7001001001
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-010-01)

Annotations

UNII (FDA Substance ID)

1678OK0E08

DEXMETHYLPHENIDATE HYDROCHLORIDE

RxCUI 353105

Orange Book

A213813

ABABABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1678OK0E08",
    "rxcui": "353105",
    "inchikey": "JUMYIBMBTDDLNG-OJERSXHUSA-N",
    "display_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "93e56455-0f15-4ed9-a63a-7fbd0697d520": {
      "match": "brand_token",
      "title": "DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "15",
      "published_date": "2026-05-04"
    }
  },
  "productid": "70010-010_412b7fd8-c12a-36c2-e063-6394a90acae6",
  "productndc": "70010-010",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213813",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "005",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "007",
        "approval_date": "Sep 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "008",
        "approval_date": "Sep 9, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
  "proprietary_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213813",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
  "start_marketing_date": "20201201",
  "active_numerator_strength": "35"
}

Related drugs

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