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United States · US · US:62559-591_65c78569-68fb-49ac-aa09-96b1fc5a01d0

InnoPran XL

In shortageOrange BookUNIISPLATC C07AA05

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

Identification

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

Packs · 3

  • ndc11
    6255959114
    14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-14)
  • ndc11
    6255959130
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-30)
  • ndc11
    6255959177
    7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-77)

Annotations

UNII (FDA Substance ID)
F8A3652H1V
PROPRANOLOL HYDROCHLORIDE
RxCUI 82084
Orange Book
N021438
BXBX
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": {
    "cd5601b3-4d87-4c3b-acac-b476e787609d": {
      "match": "brand_token",
      "title": "INNOPRAN XL (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2024-03-22"
    }
  },
  "productid": "62559-591_65c78569-68fb-49ac-aa09-96b1fc5a01d0",
  "productndc": "62559-591",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021438",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "BX",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "Mar 12, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "BX",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "Mar 12, 2003"
      }
    ],
    "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": "InnoPran XL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021438",
  "marketing_category": "NDA",
  "nonproprietary_name": "propranolol hydrochloride",
  "start_marketing_date": "20180222",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code C07AA05.

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