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United States · US · US:43602-177_eadd6980-7aad-464b-9ce8-cf7b1a20064d
Methylphenidate Hydrochloride
In shortageOrange BookUNIISPLATC N06BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscent Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114360217705500 mL in 1 BOTTLE (43602-177-05)
- ndc114360217725250 mL in 1 BOTTLE (43602-177-25)
Annotations
UNII (FDA Substance ID)
207ZZ9QZ49
METHYLPHENIDATE
RxCUI 6901
Orange Book
A207417
AAAA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylphenidate Film, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "207ZZ9QZ49",
"rxcui": "6901",
"inchikey": "DUGOZIWVEXMGBE-STQMWFEESA-N;DUGOZIWVEXMGBE-CHWSQXEVSA-N",
"display_name": "METHYLPHENIDATE",
"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": "43602-177_eadd6980-7aad-464b-9ce8-cf7b1a20064d",
"productndc": "43602-177",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207417",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Jan 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "002",
"approval_date": "Jan 29, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPHENIDATE",
"shortage_reason": "Methylphenidate Film, Extended Release",
"shortage_status": "current",
"proprietary_name": "Methylphenidate Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA207417",
"marketing_category": "ANDA",
"nonproprietary_name": "Methylphenidate Hydrochloride",
"start_marketing_date": "20210129",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N06BA04.
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