PROMETHAZINE HYDROCHLORIDE

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 · 2

ndc11
4306387601
100 TABLET in 1 BOTTLE, PLASTIC (43063-876-01)
ndc11
4306387604
4 TABLET in 1 BOTTLE, PLASTIC (43063-876-04)

Annotations

UNII (FDA Substance ID)

R61ZEH7I1I

PROMETHAZINE HYDROCHLORIDE

RxCUI 142445

Orange Book

A040712

ABABAB

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": "43063-876_526d1560-af9a-fea1-e063-6394a90af414",
  "productndc": "43063-876",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040712",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "002",
        "approval_date": "May 4, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jul 31, 2006"
      }
    ],
    "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/1",
  "application_number": "ANDA040712",
  "marketing_category": "ANDA",
  "nonproprietary_name": "promethazine hydrochloride",
  "start_marketing_date": "20060731",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code R06AD52.

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