Dexmethylphenidate hydrochloride

Orange BookUNIISPLATC N06BA11

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

Identification

ManufacturerNivagen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06BA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7583432701
100 TABLET in 1 BOTTLE (75834-327-01)

Annotations

UNII (FDA Substance ID)

1678OK0E08

DEXMETHYLPHENIDATE HYDROCHLORIDE

RxCUI 353105

Orange Book

A209211

ABAB

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": "75834-327_6103914c-da93-4648-9180-e5c439a07bc2",
  "productndc": "75834-327",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209211",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 19, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 19, 2018"
      }
    ],
    "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": "ANDA209211",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexmethylphenidate hydrochloride",
  "start_marketing_date": "20240503",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N06BA11.

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