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United States · US · US:64370-375_4629077d-5a4b-443a-e063-6294a90a48ab

HEMANGEOL

In shortageOrange BookUNIISPLATC C07AA05

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

Identification

ManufacturerPierre Fabre Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC07AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6437037501
    1 BOTTLE, GLASS in 1 CARTON (64370-375-01) / 120 mL in 1 BOTTLE, GLASS
  • ndc11
    6437037550
    1 BOTTLE, GLASS in 1 CARTON (64370-375-50) / 50 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
F8A3652H1V
PROPRANOLOL HYDROCHLORIDE
RxCUI 82084
Orange Book
N205410
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": {
    "4f8341ee-dac6-1ca9-e063-6394a90ac960": {
      "match": "brand_token",
      "title": "HEMANGEOL (PROPRANOLOL HYDROCHLORIDE) SOLUTION [ETON PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "64370-375_4629077d-5a4b-443a-e063-6294a90a48ab",
  "productndc": "64370-375",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "205410",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4.28MG/ML",
        "product_no": "001",
        "approval_date": "Mar 14, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPRANOLOL HYDROCHLORIDE",
  "shortage_reason": "Propranolol Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "HEMANGEOL",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA205410",
  "marketing_category": "NDA",
  "nonproprietary_name": "propranolol hydrochloride",
  "start_marketing_date": "20140414",
  "active_numerator_strength": "4.28"
}

Related drugs

Other records sharing ATC code C07AA05.

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