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United States · US · US:62756-301_842763a1-63ca-4721-b127-f997ac4aa659
SEZABY
In shortageOrange BookUNIISPLATC N03AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN03AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162756301011 INJECTION in 1 VIAL, SINGLE-DOSE (62756-301-01)
Annotations
UNII (FDA Substance ID)
SW9M9BB5K3
PHENOBARBITAL SODIUM
RxCUI 82077
Orange Book
N215910
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Phenobarbital Tablet
Raw payload (JSON)
{
"unii": {
"unii": "SW9M9BB5K3",
"rxcui": "82077",
"inchikey": "WRLGYAWRGXKSKG-UHFFFAOYSA-M",
"display_name": "PHENOBARBITAL SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"8c7d0402-4977-4c25-bc4b-11db91339e9a": {
"match": "brand_token",
"title": "SEZABY (PHENOBARBITAL SODIUM) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "7",
"published_date": "2025-12-26"
}
},
"productid": "62756-301_842763a1-63ca-4721-b127-f997ac4aa659",
"productndc": "62756-301",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215910",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Nov 17, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENOBARBITAL SODIUM",
"shortage_reason": "Phenobarbital Tablet",
"shortage_status": "current",
"proprietary_name": "SEZABY",
"active_ingred_unit": "mg/1",
"application_number": "NDA215910",
"marketing_category": "NDA",
"nonproprietary_name": "phenobarbital sodium",
"start_marketing_date": "20221225",
"active_numerator_strength": "100"
}Related drugs
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