🇺🇸
United States · US · US:57664-379_0d0cbfc3-ae27-b481-e063-6394a90a917c
Dexmethylphenidate hydrochloride
Orange BookUNIISPLATC N06BA11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN06BA11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115766437908100 TABLET in 1 BOTTLE (57664-379-08)
- ndc115766437913500 TABLET in 1 BOTTLE (57664-379-13)
- ndc1157664379181000 TABLET in 1 BOTTLE (57664-379-18)
- ndc11576643798330 TABLET in 1 BOTTLE (57664-379-83)
- ndc115766437988100 TABLET in 1 BOTTLE (57664-379-88)
Annotations
UNII (FDA Substance ID)
1678OK0E08
DEXMETHYLPHENIDATE HYDROCHLORIDE
RxCUI 353105
Orange Book
A201231
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": "57664-379_0d0cbfc3-ae27-b481-e063-6394a90a917c",
"productndc": "57664-379",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "201231",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Sep 24, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Sep 24, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Sep 24, 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": "ANDA201231",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexmethylphenidate hydrochloride",
"start_marketing_date": "20130926",
"active_numerator_strength": "10"
}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.