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United States · US · US:11534-157_9d9ffca5-9d09-4d92-a8af-18f9f6b24989

Phentermine Hydrochloride

In shortageOrange BookUNIISPLATC A08AA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSUNRISE PHARMACEUTICAL, INC.
CountryUS (United States)
ATC codeA08AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1153415701
    100 CAPSULE in 1 BOTTLE (11534-157-01)
  • ndc11
    1153415703
    1000 CAPSULE in 1 BOTTLE (11534-157-03)

Annotations

UNII (FDA Substance ID)
0K2I505OTV
PHENTERMINE HYDROCHLORIDE
RxCUI 82078
Orange Book
A205019
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": "11534-157_9d9ffca5-9d09-4d92-a8af-18f9f6b24989",
  "productndc": "11534-157",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205019",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Dec 5, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Dec 5, 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": "ANDA205019",
  "marketing_category": "ANDA",
  "nonproprietary_name": "phentermine hydrochloride",
  "start_marketing_date": "20170124",
  "active_numerator_strength": "15"
}

Related drugs

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