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United States · US · US:62559-523_ca8f11e2-bf38-474e-9929-43c522be09ea
INDERAL
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 · 2
- ndc116255952301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-01)
- ndc11625595233030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-30)
Annotations
UNII (FDA Substance ID)
F8A3652H1V
PROPRANOLOL HYDROCHLORIDE
RxCUI 82084
Orange Book
N018553
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": {
"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": "62559-523_ca8f11e2-bf38-474e-9929-43c522be09ea",
"productndc": "62559-523",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "018553",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "160MG",
"product_no": "001",
"approval_date": "Apr 19, 1983"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "80MG",
"product_no": "002",
"approval_date": "Apr 19, 1983"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "120MG",
"product_no": "003",
"approval_date": "Apr 19, 1983"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "60MG",
"product_no": "004",
"approval_date": "Mar 18, 1987"
}
],
"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",
"active_ingred_unit": "mg/1",
"application_number": "NDA018553",
"marketing_category": "NDA",
"nonproprietary_name": "propranolol hydrochloride",
"start_marketing_date": "20170428",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C07AA05.
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