🇺🇸
United States · US · US:24478-322_471e97b5-a75c-4901-be57-f77ad6a7856f
Quillivant
In shortageOrange BookUNIISPLATC N06BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNextWave Pharmaceuticals, Inc
CountryUS (United States)
ATC codeN06BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124478322041 BOTTLE in 1 CARTON (24478-322-04) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4B3SC438HI
METHYLPHENIDATE HYDROCHLORIDE
RxCUI 203188
Orange Book
N202100
AB
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": {
"c2dc2109-44a6-4797-b04e-18761dd9d45a": {
"match": "brand_token",
"title": "QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) SUSPENSION, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC]",
"spl_version": "20",
"published_date": "2026-03-23"
}
},
"productid": "24478-322_471e97b5-a75c-4901-be57-f77ad6a7856f",
"productndc": "24478-322",
"dosage_form": "SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "202100",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "5MG/ML",
"product_no": "001",
"approval_date": "Sep 27, 2012"
}
],
"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": "Quillivant",
"active_ingred_unit": "mg/120mL",
"application_number": "NDA202100",
"marketing_category": "NDA",
"nonproprietary_name": "methylphenidate hydrochloride",
"start_marketing_date": "20121001",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N06BA04.
Access this data programmatically
Query Quillivant 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.