Promethazine Hydrochloride

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133511390
14 TABLET in 1 BOTTLE (71335-1139-0)
ndc11
7133511391
15 TABLET in 1 BOTTLE (71335-1139-1)
ndc11
7133511392
30 TABLET in 1 BOTTLE (71335-1139-2)
ndc11
7133511393
10 TABLET in 1 BOTTLE (71335-1139-3)
ndc11
7133511394
20 TABLET in 1 BOTTLE (71335-1139-4)
ndc11
7133511395
12 TABLET in 1 BOTTLE (71335-1139-5)
ndc11
7133511396
60 TABLET in 1 BOTTLE (71335-1139-6)
ndc11
7133511397
90 TABLET in 1 BOTTLE (71335-1139-7)
ndc11
7133511398
6 TABLET in 1 BOTTLE (71335-1139-8)
ndc11
7133511399
56 TABLET in 1 BOTTLE (71335-1139-9)

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": {
    "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": "71335-1139_b02527e6-b912-4a80-8d6a-a78a7685dc55",
  "productndc": "71335-1139",
  "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": "Promethazine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040596",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Promethazine Hydrochloride",
  "start_marketing_date": "20051214",
  "active_numerator_strength": "25"
}

Related drugs

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