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 · 13

ndc11
4306359601
100 TABLET in 1 BOTTLE, PLASTIC (43063-596-01)
ndc11
4306359607
7 TABLET in 1 BOTTLE, PLASTIC (43063-596-07)
ndc11
4306359614
14 TABLET in 1 BOTTLE, PLASTIC (43063-596-14)
ndc11
4306359615
15 TABLET in 1 BOTTLE, PLASTIC (43063-596-15)
ndc11
4306359621
21 TABLET in 1 BOTTLE, PLASTIC (43063-596-21)
ndc11
4306359628
28 TABLET in 1 BOTTLE, PLASTIC (43063-596-28)
ndc11
4306359630
30 TABLET in 1 BOTTLE, PLASTIC (43063-596-30)
ndc11
4306359632
32 TABLET in 1 BOTTLE, PLASTIC (43063-596-32)
ndc11
4306359642
42 TABLET in 1 BOTTLE, PLASTIC (43063-596-42)
ndc11
4306359645
45 TABLET in 1 BOTTLE, PLASTIC (43063-596-45)
ndc11
4306359660
60 TABLET in 1 BOTTLE, PLASTIC (43063-596-60)
ndc11
4306359690
90 TABLET in 1 BOTTLE, PLASTIC (43063-596-90)
ndc11
4306359693
180 TABLET in 1 BOTTLE, PLASTIC (43063-596-93)

Annotations

UNII (FDA Substance ID)

0K2I505OTV

PHENTERMINE HYDROCHLORIDE

RxCUI 82078

Orange Book

A040526

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": "43063-596_4139a2e1-0cbe-32df-e063-6394a90a346e",
  "productndc": "43063-596",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040526",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "37.5MG",
        "product_no": "001",
        "approval_date": "Oct 23, 2003"
      }
    ],
    "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": "ANDA040526",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentermine Hydrochloride",
  "start_marketing_date": "20130812",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code A08AA01.

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