Promethazine Hydrochloride

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009008790
25 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-0879-0) / 1 mL in 1 VIAL, SINGLE-DOSE

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",
  "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": "50090-0879_5cb280fa-c45d-4dbb-8e1d-c2271db20a77",
  "productndc": "50090-0879",
  "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": "19730919",
  "active_numerator_strength": "50"
}

Related drugs

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