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United States · US · US:84053-910_48fd28f6-101b-498c-e063-6294a90aba52

Phentermine Hydrochloride

In shortageOrange BookUNIISPLATC A08AA01

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

Identification

ManufacturerMartek Pharmacal Co.
CountryUS (United States)
ATC codeA08AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8405391007
    7 CAPSULE in 1 BOTTLE (84053-910-07)
  • ndc11
    8405391014
    14 CAPSULE in 1 BOTTLE (84053-910-14)
  • ndc11
    8405391021
    21 CAPSULE in 1 BOTTLE (84053-910-21)

Annotations

UNII (FDA Substance ID)
0K2I505OTV
PHENTERMINE HYDROCHLORIDE
RxCUI 82078
Orange Book
A202248
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": "84053-910_48fd28f6-101b-498c-e063-6294a90aba52",
  "productndc": "84053-910",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202248",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2012"
      }
    ],
    "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": "ANDA202248",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentermine Hydrochloride",
  "start_marketing_date": "20240212",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code A08AA01.

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