Promethazine Hydrochloride

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerHenry Schein, Inc.

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0404994101
1 AMPULE in 1 BAG (0404-9941-01) / 1 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

R61ZEH7I1I

PROMETHAZINE HYDROCHLORIDE

RxCUI 142445

Orange Book

A083312

APAP

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": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d": {
      "match": "brand_token",
      "title": "PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "19",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0404-9941_64108fe9-f7f8-44f8-ab3a-7714a8917ea2",
  "productndc": "0404-9941",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "083312",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "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": "Promethazine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA083312",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Promethazine Hydrochloride",
  "start_marketing_date": "20220117",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AD52.

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