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United States · US · US:62559-601_2b2778d4-efb2-4541-8264-375ad6082cb6
Inderal 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
- ndc11625596011414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14)
- ndc11625596013030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30)
- ndc1162559601777 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77)
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": {
"35d28979-36b1-4630-b85e-a44e0a443734": {
"match": "brand_token",
"title": "INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2024-08-02"
}
},
"productid": "62559-601_2b2778d4-efb2-4541-8264-375ad6082cb6",
"productndc": "62559-601",
"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": "Inderal 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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