Phentermine and Topiramate Extended-Release

In shortageOrange BookUNIISPLATC A08AA

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeA08AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359862530
30 CAPSULE in 1 BOTTLE (43598-625-30)

Annotations

UNII (FDA Substance ID)

0K2I505OTV

PHENTERMINE HYDROCHLORIDE

RxCUI 82078

Orange Book

A208175

ABABABAB

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": "43598-625_ce37425a-12f1-722f-ab5b-d95615c635a0",
  "productndc": "43598-625",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208175",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3.75MG BASE;23MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 7.5MG BASE;46MG",
        "product_no": "002",
        "approval_date": "Jun 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 11.25MG BASE;69MG",
        "product_no": "003",
        "approval_date": "Jun 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 15MG BASE;92MG",
        "product_no": "004",
        "approval_date": "Jun 12, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENTERMINE HYDROCHLORIDE; TOPIRAMATE",
  "shortage_reason": "Phentermine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Phentermine and Topiramate Extended-Release",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208175",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentermine and Topiramate Extended-Release",
  "start_marketing_date": "20250612",
  "active_numerator_strength": "7.5; 46"
}

Related drugs

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