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United States · US · US:63323-659_18ca75fc-a45c-42a4-b966-9d3ae4821de8
Indomethacin
Orange BookUNIISPLATC C01EB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeC01EB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323659031 VIAL in 1 CARTON (63323-659-03) / 1 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
XXE1CET956
INDOMETHACIN
RxCUI 5781
Orange Book
N022536
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XXE1CET956",
"rxcui": "5781",
"inchikey": "CGIGDMFJXJATDK-UHFFFAOYSA-N",
"display_name": "INDOMETHACIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"009097a5-2c1e-4f5d-8054-896cf896cb3d": {
"match": "brand_token",
"title": "INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "17",
"published_date": "2026-05-28"
}
},
"productid": "63323-659_18ca75fc-a45c-42a4-b966-9d3ae4821de8",
"productndc": "63323-659",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "022536",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE/VIAL",
"product_no": "001",
"approval_date": "Mar 17, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INDOMETHACIN",
"proprietary_name": "Indomethacin",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022536",
"marketing_category": "NDA",
"nonproprietary_name": "INDOMETHACIN",
"start_marketing_date": "20100319",
"active_numerator_strength": "1"
}Related drugs
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