Phentermine Hydrochloride

In shortageOrange BookUNIISPLATC A08AA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA08AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5348967601
100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01)
ndc11
5348967603
250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03)
ndc11
5348967605
500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05)
ndc11
5348967606
60 TABLET in 1 BOTTLE, PLASTIC (53489-676-06)
ndc11
5348967607
30 TABLET in 1 BOTTLE, PLASTIC (53489-676-07)
ndc11
5348967610
1000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10)

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": "53489-676_39e24c57-7266-2bf6-e063-6294a90afdd1",
  "productndc": "53489-676",
  "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": "37.5"
}

Related drugs

Other records sharing ATC code A08AA01.

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