Propranolol Hydrochloride

In shortageOrange BookUNIISPLATC C07AA05

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC07AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054373063
500 mL in 1 BOTTLE, PLASTIC (0054-3730-63)

Annotations

UNII (FDA Substance ID)

F8A3652H1V

PROPRANOLOL HYDROCHLORIDE

RxCUI 82084

Orange Book

A070690

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Propranolol Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "F8A3652H1V",
    "rxcui": "82084",
    "inchikey": "ZMRUPTIKESYGQW-UHFFFAOYSA-N",
    "display_name": "PROPRANOLOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4dd23053-0458-40f2-ac34-afb8cc9903aa": {
      "match": "brand_token",
      "title": "PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0054-3730_245a43cc-cbf8-486d-ad3c-724aca63fd72",
  "productndc": "0054-3730",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "070690",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "40MG/5ML",
        "product_no": "001",
        "approval_date": "May 15, 1987"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "20MG/5ML",
        "product_no": "002",
        "approval_date": "May 15, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPRANOLOL HYDROCHLORIDE",
  "shortage_reason": "Propranolol Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Propranolol Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA070690",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Propranolol Hydrochloride",
  "start_marketing_date": "19870515",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code C07AA05.

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