Propranolol Hydrochloride

In shortageOrange BookUNIISPLATC C07AA05

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

Identification

ManufacturerIpca Laboratories Limited

CountryUS (United States)

ATC codeC07AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8398000501
100 TABLET in 1 BOTTLE (83980-005-01)
ndc11
8398000505
500 TABLET in 1 BOTTLE (83980-005-05)
ndc11
8398000510
1000 TABLET in 1 BOTTLE (83980-005-10)
ndc11
8398000513
30 TABLET in 1 BOTTLE (83980-005-13)

Annotations

UNII (FDA Substance ID)

F8A3652H1V

PROPRANOLOL HYDROCHLORIDE

RxCUI 82084

Orange Book

A078955

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": "83980-005_7854dd0a-2a35-4d7f-afe4-210b28966928",
  "productndc": "83980-005",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078955",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jun 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Jun 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Jun 2, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Jun 2, 2008"
      }
    ],
    "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": "ANDA078955",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Propranolol Hydrochloride",
  "start_marketing_date": "20240919",
  "active_numerator_strength": "10"
}

Related drugs

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