PROMETHEGAN

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5528992802
2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02)
ndc11
5528992804
4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04)
ndc11
5528992806
6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06)
ndc11
5528992879
1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79)

Annotations

UNII (FDA Substance ID)

R61ZEH7I1I

PROMETHAZINE HYDROCHLORIDE

RxCUI 142445

Orange Book

A040428

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Promethazine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "R61ZEH7I1I",
    "rxcui": "142445",
    "inchikey": "XXPDBLUZJRXNNZ-UHFFFAOYSA-N",
    "display_name": "PROMETHAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RECTAL",
  "spl_meta": {
    "6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97": {
      "match": "brand_token",
      "title": "PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2025-11-17"
    }
  },
  "productid": "55289-928_419b860e-68c0-f896-e063-6294a90aceb9",
  "productndc": "55289-928",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "040428",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 5, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "002",
        "approval_date": "Mar 31, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROMETHAZINE HYDROCHLORIDE",
  "shortage_reason": "Promethazine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "PROMETHEGAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040428",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Promethazine Hydrochloride",
  "start_marketing_date": "20020228",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AD52.

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