Dexmethylphenidate Hydrochloride

Orange BookUNIISPLATC N06BA11

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

Identification

ManufacturerKVK-TECH, INC

CountryUS (United States)

ATC codeN06BA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1070210801
100 TABLET in 1 BOTTLE (10702-108-01)

Annotations

UNII (FDA Substance ID)

1678OK0E08

DEXMETHYLPHENIDATE HYDROCHLORIDE

RxCUI 353105

Orange Book

A206931

ABABAB

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": "10702-108_445dff50-b3a4-8602-e063-6294a90aef3b",
  "productndc": "10702-108",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206931",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Dec 4, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Dec 4, 2015"
      }
    ],
    "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": "ANDA206931",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexmethylphenidate Hydrochloride",
  "start_marketing_date": "20151204",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA11.

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