Phentermine Hydrochloride

In shortageOrange BookUNIISPLATC A08AA01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA08AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306396101
100 CAPSULE in 1 BOTTLE, PLASTIC (43063-961-01)

Annotations

UNII (FDA Substance ID)

0K2I505OTV

PHENTERMINE HYDROCHLORIDE

RxCUI 82078

Orange Book

A040886

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": "43063-961_415f45d4-861d-6191-e063-6394a90a2a0a",
  "productndc": "43063-961",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "040886",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Mar 31, 2008"
      }
    ],
    "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": "ANDA040886",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentermine Hydrochloride",
  "start_marketing_date": "20120807",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code A08AA01.

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