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United States · US · US:43353-961_49006163-8921-6eaf-e063-6394a90a39c2

Propranolol Hydrochloride

In shortageOrange BookUNIISPLATC C07AA05

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC07AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4335396160
    90 TABLET in 1 BOTTLE, PLASTIC (43353-961-60)

Annotations

UNII (FDA Substance ID)
F8A3652H1V
PROPRANOLOL HYDROCHLORIDE
RxCUI 82084
Orange Book
A070213
ABABABABAB
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": "43353-961_49006163-8921-6eaf-e063-6394a90a39c2",
  "productndc": "43353-961",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070213",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Nov 19, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 19, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 19, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Nov 19, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "005",
        "approval_date": "Apr 8, 2011"
      }
    ],
    "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/1",
  "application_number": "ANDA070213",
  "marketing_category": "ANDA",
  "nonproprietary_name": "propranolol hydrochloride",
  "start_marketing_date": "19851119",
  "active_numerator_strength": "20"
}

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