LOMAIRA

In shortageOrange BookUNIISPLATC A08AA01

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

Identification

ManufacturerKVK-TECH, INC.

CountryUS (United States)

ATC codeA08AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
1070200103
30 TABLET in 1 BOTTLE (10702-001-03)
ndc11
1070200106
60 TABLET in 1 BOTTLE (10702-001-06)
ndc11
1070200109
90 TABLET in 1 BOTTLE (10702-001-09)
ndc11
1070200110
1000 TABLET in 1 BOTTLE (10702-001-10)
ndc11
1070200125
250 TABLET in 1 BOTTLE (10702-001-25)
ndc11
1070200150
500 TABLET in 1 BOTTLE (10702-001-50)

Annotations

UNII (FDA Substance ID)

0K2I505OTV

PHENTERMINE HYDROCHLORIDE

RxCUI 82078

Orange Book

A203495

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": "10702-001_0ce01306-ef7f-563f-e063-6394a90a52b7",
  "productndc": "10702-001",
  "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

Other records sharing ATC code A08AA01.

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