PROMETHAZINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerNostrum Laboratories, Inc.

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2903350034
473 mL in 1 BOTTLE (29033-500-34)

Annotations

UNII (FDA Substance ID)

R61ZEH7I1I

PROMETHAZINE HYDROCHLORIDE

RxCUI 142445

Orange Book

A040891

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": "ORAL",
  "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": "29033-500_de4790d2-95c1-46e1-b8c6-f5bc14abcdbb",
  "productndc": "29033-500",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040891",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "6.25MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 13, 2009"
      }
    ],
    "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/5mL",
  "application_number": "ANDA040891",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROMETHAZINE HYDROCHLORIDE",
  "start_marketing_date": "20240718",
  "active_numerator_strength": "6.25"
}

Related drugs

Other records sharing ATC code R06AD52.

Access this data programmatically

Query PROMETHAZINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs