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United States · US · US:59630-755_64c7c464-4ef5-401a-ab3c-c0443e5e31a5
Methylin
In shortageOrange BookUNIISPLATC N06BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSHIONOGI INC.
CountryUS (United States)
ATC codeN06BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115963075550500 mL in 1 BOTTLE (59630-755-50)
Annotations
UNII (FDA Substance ID)
4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE
RxCUI 203188
Orange Book
N021419
AAAA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylphenidate Hydrochloride Tablet, 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": {
"9e3c22d9-71d9-46a7-b315-8021c94c4bec": {
"match": "brand_token",
"title": "METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]",
"spl_version": "32",
"published_date": "2024-07-24"
}
},
"productid": "59630-755_64c7c464-4ef5-401a-ab3c-c0443e5e31a5",
"productndc": "59630-755",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "021419",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Dec 19, 2002"
},
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "002",
"approval_date": "Dec 19, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
"shortage_reason": "Methylphenidate Hydrochloride Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "Methylin",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA021419",
"marketing_category": "NDA",
"nonproprietary_name": "Methylphenidate Hydrochloride",
"start_marketing_date": "20021219",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06BA04.
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