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United States · US · US:13107-106_53dd7857-41fb-4da1-88f7-5c68a509bfb0
Phentermine
In shortageOrange BookUNIISPLATC A08AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeA08AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111310710601100 CAPSULE in 1 BOTTLE (13107-106-01)
- ndc11131071063030 CAPSULE in 1 BOTTLE (13107-106-30)
Annotations
UNII (FDA Substance ID)
0K2I505OTV
PHENTERMINE HYDROCHLORIDE
RxCUI 82078
Orange Book
A204318
AAAA
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": {
"27e88ebe-6247-4598-8ef2-c882992ed579": {
"match": "brand_token",
"title": "PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [CALVIN SCOTT & CO., INC.]",
"spl_version": "4",
"published_date": "2026-06-01"
}
},
"productid": "13107-106_53dd7857-41fb-4da1-88f7-5c68a509bfb0",
"productndc": "13107-106",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204318",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "15MG",
"product_no": "001",
"approval_date": "Nov 9, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "30MG",
"product_no": "002",
"approval_date": "Nov 9, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENTERMINE HYDROCHLORIDE",
"shortage_reason": "Phentermine Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Phentermine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204318",
"marketing_category": "ANDA",
"nonproprietary_name": "Phentermine Hydrochloride",
"start_marketing_date": "20170320",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code A08AA01.
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