Phentermine Hydrochloride

In shortageOrange BookUNIISPLATC A08AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurolife Pharma, LLC

CountryUS (United States)

ATC codeA08AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1310706101
100 TABLET in 1 BOTTLE (13107-061-01)
ndc11
1310706105
500 TABLET in 1 BOTTLE (13107-061-05)
ndc11
1310706130
30 TABLET in 1 BOTTLE (13107-061-30)
ndc11
1310706199
1000 TABLET in 1 BOTTLE (13107-061-99)

Annotations

UNII (FDA Substance ID)

0K2I505OTV

PHENTERMINE HYDROCHLORIDE

RxCUI 82078

Orange Book

A203068

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": "13107-061_0add1627-bf2b-40ba-b5a4-1cf580496a38",
  "productndc": "13107-061",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203068",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "37.5MG",
        "product_no": "001",
        "approval_date": "Aug 6, 2014"
      }
    ],
    "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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203068",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentermine Hydrochloride",
  "start_marketing_date": "20140806",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code A08AA01.

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