phentermine and topiramate

In shortageOrange BookUNIISPLATC A08AA

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeA08AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699378330
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-783-30)

Annotations

UNII (FDA Substance ID)

0K2I505OTV

PHENTERMINE HYDROCHLORIDE

RxCUI 82078

Orange Book

N022580

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": "66993-783_52217277-c719-2f2f-e063-6394a90a6699",
  "productndc": "66993-783",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022580",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 3.75MG BASE;23MG",
        "product_no": "001",
        "approval_date": "Jul 17, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 7.5MG BASE;46MG",
        "product_no": "002",
        "approval_date": "Jul 17, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 11.25MG BASE;69MG",
        "product_no": "003",
        "approval_date": "Jul 17, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 15MG BASE;92MG",
        "product_no": "004",
        "approval_date": "Jul 17, 2012"
      }
    ],
    "appl_type": "N"
  },
  "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",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022580",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "phentermine and topiramate",
  "start_marketing_date": "20250601",
  "active_numerator_strength": "15; 92"
}

Related drugs

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