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United States · US · US:84549-604_45b0aaf0-df6d-7db0-e063-6294a90a9135

Propranolol

In shortageOrange BookUNIISPLATC C07AA05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProPharma Distribution
CountryUS (United States)
ATC codeC07AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8454960401
    1 mL in 1 VIAL, SINGLE-DOSE (84549-604-01)

Annotations

UNII (FDA Substance ID)
F8A3652H1V
PROPRANOLOL HYDROCHLORIDE
RxCUI 82084
Orange Book
A075826
AP
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": "INTRAVENOUS",
  "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": "84549-604_45b0aaf0-df6d-7db0-e063-6294a90a9135",
  "productndc": "84549-604",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075826",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Aug 31, 2001"
      }
    ],
    "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",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075826",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROPRANOLOL HYDROCHLORIDE",
  "start_marketing_date": "20010907",
  "active_numerator_strength": "1"
}

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