🇺🇸
United States · US · US:0115-9920_4fcd36f9-1e85-437f-9f27-0e2942480c7f
Dexmethylphenidate hydrochloride
Orange BookUNIISPLATC N06BA11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN06BA11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110115992001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-9920-01)
Annotations
UNII (FDA Substance ID)
1678OK0E08
DEXMETHYLPHENIDATE HYDROCHLORIDE
RxCUI 353105
Orange Book
A079108
ABABABABAB
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": "0115-9920_4fcd36f9-1e85-437f-9f27-0e2942480c7f",
"productndc": "0115-9920",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "079108",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 5, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 5, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "May 19, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "004",
"approval_date": "Dec 21, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "005",
"approval_date": "Nov 21, 2013"
}
],
"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": "ANDA079108",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexmethylphenidate hydrochloride",
"start_marketing_date": "20141111",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N06BA11.
- GBDexmethylphenidate 10mg modified-release capsulesSpecial Order
- 🇺🇸Dexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLC
- 🇺🇸Dexmethylphenidate hydrochlorideSun Pharmaceutical Industries, Inc.
- 🇺🇸Dexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLC
- 🇺🇸Dexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLC
- 🇺🇸Dexmethylphenidate hydrochlorideNivagen Pharmaceuticals, Inc.
- 🇺🇸Dexmethylphenidate hydrochlorideNivagen Pharmaceuticals, Inc.
- 🇺🇸Dexmethylphenidate hydrochlorideAmneal Pharmaceuticals of New York LLC
Access this data programmatically
Query Dexmethylphenidate hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.