Phenergan

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7218940210
10 TABLET in 1 BOTTLE (72189-402-10)
ndc11
7218940212
12 TABLET in 1 BOTTLE (72189-402-12)
ndc11
7218940230
30 TABLET in 1 BOTTLE (72189-402-30)

Annotations

UNII (FDA Substance ID)

R61ZEH7I1I

PROMETHAZINE HYDROCHLORIDE

RxCUI 142445

Orange Book

A040596

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": {
    "eec705f7-123a-7926-e053-2a95a90af46d": {
      "match": "brand_token",
      "title": "PHENERGAN (PROMETHAZINE HCL) TABLET [DIRECT_RX]",
      "spl_version": "3",
      "published_date": "2026-03-09"
    }
  },
  "productid": "72189-402_4c4baadf-895a-bd8e-e063-6294a90ad228",
  "productndc": "72189-402",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040596",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Nov 18, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Nov 18, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Nov 18, 2005"
      }
    ],
    "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": "Phenergan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040596",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Promethazine HCL",
  "start_marketing_date": "20221201",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code R06AD52.

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