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United States · US · US:66758-274_3cf2c541-a65c-4651-ab30-3451a5581f8f
Ritalin
In shortageOrange BookUNIISPLATC N06BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN06BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116675827401100 TABLET in 1 BOTTLE (66758-274-01)
Annotations
UNII (FDA Substance ID)
4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE
RxCUI 203188
Orange Book
N010187
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylphenidate Film, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "4B3SC438HI",
"rxcui": "203188",
"inchikey": "JUMYIBMBTDDLNG-OJERSXHUSA-N;JUMYIBMBTDDLNG-QNTKWALQSA-N",
"display_name": "METHYLPHENIDATE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"effd952d-ac94-47bb-b107-589a4934dcca": {
"match": "brand_token",
"title": "RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "36",
"published_date": "2025-10-01"
}
},
"productid": "66758-274_3cf2c541-a65c-4651-ab30-3451a5581f8f",
"productndc": "66758-274",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "010187",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "006",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "010",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
"shortage_reason": "Methylphenidate Film, Extended Release",
"shortage_status": "current",
"proprietary_name": "Ritalin",
"active_ingred_unit": "mg/1",
"application_number": "NDA010187",
"marketing_category": "NDA",
"nonproprietary_name": "methylphenidate hydrochloride",
"start_marketing_date": "19551231",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06BA04.
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