Phentermine Hydrochloride

In shortageOrange BookUNIISPLATC A08AA01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA08AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6318780007
7 TABLET in 1 BOTTLE (63187-800-07)
ndc11
6318780014
14 TABLET in 1 BOTTLE (63187-800-14)
ndc11
6318780015
15 TABLET in 1 BOTTLE (63187-800-15)
ndc11
6318780030
30 TABLET in 1 BOTTLE (63187-800-30)
ndc11
6318780060
60 TABLET in 1 BOTTLE (63187-800-60)

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": "63187-800_4e1cdc95-3d6c-4a43-8aec-194daf2abd12",
  "productndc": "63187-800",
  "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": "20110610",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code A08AA01.

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