Promethazine

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerPharmPak, Inc.

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
5434811700
1 BOTTLE in 1 BOX (54348-117-00) / 1 TABLET in 1 BOTTLE
ndc11
5434811702
1 BOTTLE in 1 BOX (54348-117-02) / 2 TABLET in 1 BOTTLE
ndc11
5434811703
1 BOTTLE in 1 BOX (54348-117-03) / 3 TABLET in 1 BOTTLE
ndc11
5434811704
1 BOTTLE in 1 BOX (54348-117-04) / 4 TABLET in 1 BOTTLE
ndc11
5434811705
1 BOTTLE in 1 BOX (54348-117-05) / 5 TABLET in 1 BOTTLE
ndc11
5434811706
1 BOTTLE in 1 BOX (54348-117-06) / 6 TABLET in 1 BOTTLE
ndc11
5434811708
1 BOTTLE in 1 BOX (54348-117-08) / 8 TABLET in 1 BOTTLE
ndc11
5434811709
1 BOTTLE in 1 BOX (54348-117-09) / 9 TABLET in 1 BOTTLE
ndc11
5434811710
1 BOTTLE in 1 BOX (54348-117-10) / 10 TABLET in 1 BOTTLE
ndc11
5434811712
1 BOTTLE in 1 BOX (54348-117-12) / 12 TABLET in 1 BOTTLE

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": "54348-117_ea92baba-9184-5d68-e053-2a95a90a5e8f",
  "productndc": "54348-117",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040712",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROMETHAZINE",
  "start_marketing_date": "20190711",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AD52.

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