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United States · US · US:50090-7560_71a854a1-d9af-4f37-a43c-ba3cafafc2c5

LOMAIRA

In shortageOrange BookUNIISPLATC A08AA01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA08AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009075600
    90 TABLET in 1 BOTTLE (50090-7560-0)

Annotations

UNII (FDA Substance ID)
0K2I505OTV
PHENTERMINE HYDROCHLORIDE
RxCUI 82078
Orange Book
A203495
AA
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": {
    "0718f0f3-77f2-45d7-be12-1ed718c8b806": {
      "match": "brand_token",
      "title": "LOMAIRA (PHENTERMINE HYDROCHLORIDE) TABLET [CALVIN SCOTT & CO., INC.]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-7560_71a854a1-d9af-4f37-a43c-ba3cafafc2c5",
  "productndc": "50090-7560",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203495",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "8MG",
        "product_no": "001",
        "approval_date": "Sep 12, 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": "LOMAIRA",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203495",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentermine Hydrochloride",
  "start_marketing_date": "20160912",
  "active_numerator_strength": "8"
}

Related drugs

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