PROMETHAZINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6213577423
2 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10)
ndc11
6213577424
2 TRAY in 1 BOX (62135-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05)
ndc11
6213577441
120 mL in 1 BOTTLE (62135-774-41)
ndc11
6213577447
473 mL in 1 BOTTLE (62135-774-47)

Annotations

UNII (FDA Substance ID)

R61ZEH7I1I

PROMETHAZINE HYDROCHLORIDE

RxCUI 142445

Orange Book

A040026

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": "62135-774_499ebc74-646b-4e6d-e063-6394a90ab998",
  "productndc": "62135-774",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040026",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "6.25MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 25, 1998"
      }
    ],
    "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": "ANDA040026",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROMETHAZINE HYDROCHLORIDE",
  "start_marketing_date": "19980925",
  "active_numerator_strength": "6.25"
}

Related drugs

Other records sharing ATC code R06AD52.

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