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United States · US · US:10702-102_476dd35a-34a9-02dd-e063-6394a90a912a
Methylphenidate Hydrochloride
In shortageOrange BookUNIISPLATC N06BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKVK-TECH, INC.
CountryUS (United States)
ATC codeN06BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111070210201100 TABLET in 1 BOTTLE (10702-102-01)
Annotations
UNII (FDA Substance ID)
4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE
RxCUI 203188
Orange Book
A206932
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": {
"f7a7ffd1-bc30-4db8-8391-dddf76acd639": {
"match": "brand_token",
"title": "METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS LLC]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "10702-102_476dd35a-34a9-02dd-e063-6394a90a912a",
"productndc": "10702-102",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206932",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 11, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "May 11, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "May 11, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
"shortage_reason": "Methylphenidate Film, Extended Release",
"shortage_status": "current",
"proprietary_name": "Methylphenidate Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206932",
"marketing_category": "ANDA",
"nonproprietary_name": "Methylphenidate Hydrochloride",
"start_marketing_date": "20170511",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06BA04.
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