🇺🇸
United States · US · US:62541-201_5010eb88-287a-9597-e063-6394a90aad40
Qsymia
In shortageOrange BookUNIISPLATC A08AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVivus LLC
CountryUS (United States)
ATC codeA08AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11625412011414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14)
- ndc11625412013030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)
Annotations
UNII (FDA Substance ID)
0K2I505OTV
PHENTERMINE HYDROCHLORIDE
RxCUI 82078
Orange Book
N022580
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Phentermine Hydrochloride Tablet
Raw payload (JSON)
{
"unii": {
"unii": "0K2I505OTV",
"rxcui": "82078",
"inchikey": "NCAIGTHBQTXTLR-UHFFFAOYSA-N",
"display_name": "PHENTERMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"40dd5602-53da-45ac-bb4b-15789aba40f9": {
"match": "brand_token",
"title": "QSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS LLC]",
"spl_version": "42",
"published_date": "2026-04-24"
}
},
"productid": "62541-201_5010eb88-287a-9597-e063-6394a90aad40",
"productndc": "62541-201",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "022580",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 3.75MG BASE;23MG",
"product_no": "001",
"approval_date": "Jul 17, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 7.5MG BASE;46MG",
"product_no": "002",
"approval_date": "Jul 17, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 11.25MG BASE;69MG",
"product_no": "003",
"approval_date": "Jul 17, 2012"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 15MG BASE;92MG",
"product_no": "004",
"approval_date": "Jul 17, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
"shortage_reason": "Phentermine Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Qsymia",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA022580",
"marketing_category": "NDA",
"nonproprietary_name": "phentermine and topiramate",
"start_marketing_date": "20120917",
"active_numerator_strength": "3.75; 23"
}Related drugs
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