Back to search
🇺🇸

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

  • ndc11
    6275630101
    1 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

Other records sharing ATC code N03AA02.

Access this data programmatically

Query SEZABY and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.