Promethazine Hydrochloride

In shortageOrange BookUNIISPLATC R06AD52

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

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeR06AD52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8706301400
1000 TABLET in 1 BOTTLE (87063-014-00)
ndc11
8706301401
100 TABLET in 1 BOTTLE (87063-014-01)
ndc11
8706301405
500 TABLET in 1 BOTTLE (87063-014-05)
ndc11
8706301410
10 TABLET in 1 BOTTLE (87063-014-10)
ndc11
8706301420
20 TABLET in 1 BOTTLE (87063-014-20)
ndc11
8706301430
30 TABLET in 1 BOTTLE (87063-014-30)
ndc11
8706301460
60 TABLET in 1 BOTTLE (87063-014-60)
ndc11
8706301490
90 TABLET in 1 BOTTLE (87063-014-90)

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": "87063-014_41a47d00-8acc-6eba-e063-6294a90ae752",
  "productndc": "87063-014",
  "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": "12.5"
}

Related drugs

Other records sharing ATC code R06AD52.

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