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United States · US · US:51991-819_f7b4203a-c93c-47a2-9ad0-41df7d7a2c26

propranolol hydrochloride

In shortageOrange BookUNIISPLATC C07AA05

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

Identification

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

Packs · 2

  • ndc11
    5199181901
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51991-819-01)
  • ndc11
    5199181905
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51991-819-05)

Annotations

UNII (FDA Substance ID)
F8A3652H1V
PROPRANOLOL HYDROCHLORIDE
RxCUI 82084
Orange Book
A078703
ABABABAB
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": "51991-819_f7b4203a-c93c-47a2-9ad0-41df7d7a2c26",
  "productndc": "51991-819",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078703",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Jul 15, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Jul 15, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "003",
        "approval_date": "Jul 15, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "004",
        "approval_date": "Jul 15, 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": "ANDA078703",
  "marketing_category": "ANDA",
  "nonproprietary_name": "propranolol hydrochloride",
  "start_marketing_date": "20130311",
  "active_numerator_strength": "120"
}

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