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United States · US · US:67877-657_d87ba2c9-5dd1-4038-8149-7ef46c421422

Dexmethylphenidate Hydrochloride

Orange BookUNIISPLATC N06BA11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeN06BA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6787765701
    100 TABLET in 1 BOTTLE (67877-657-01)
  • ndc11
    6787765705
    500 TABLET in 1 BOTTLE (67877-657-05)
  • ndc11
    6787765730
    30 TABLET in 1 BOTTLE (67877-657-30)

Annotations

UNII (FDA Substance ID)
1678OK0E08
DEXMETHYLPHENIDATE HYDROCHLORIDE
RxCUI 353105
Orange Book
A212631
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": "67877-657_d87ba2c9-5dd1-4038-8149-7ef46c421422",
  "productndc": "67877-657",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212631",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jul 19, 2019"
      }
    ],
    "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": "ANDA212631",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexmethylphenidate Hydrochloride",
  "start_marketing_date": "20190721",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA11.

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